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NCT02052778 · STUDY IN CONTEXT

A Study of TAS-120 in Patients With Advanced Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

MTD:Highest dose level at which \<33% of participants experience dose-limiting toxicity (DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.

Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered.

→

primary · POSTED

RP2D was MTD or less. MTD: Highest dose level at which \<33% of participants experience DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.

Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered.

→

primary · POSTED

Objective response was defined as proportion of participants who had achieved best overall response of partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 millimeters (mm) and PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions. For Cohorts 1 to 6: Objective response was based on Independent Review Committee (IRC) and for pooled Sub-cohort: Objective response was based on investigator review.

Efficacy population included all participants who had received at least 1 dose of TAS-120. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1and 2.

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primary · POSTED

Objective response was defined as proportion of participants who had achieved best overall response of PR or CR per RECIST v1.1. CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 mm and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. The Phase 2 evaluation of objective response was based on central independent CT/MRI image assessment.

Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120.

→

secondary · POSTED

A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. For Cohorts 1 to 6: DOR was based on IRC and for Group 3, 4, 5, 6 and for pooled Sub-cohort: DOR was based on investigator review.

Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1 and 2.

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secondary · POSTED

A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. Kaplan-Meier method was used for the analysis.

Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EQ-5D · Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Scores at Specified Visits

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
qol key
qol-0012
source section id
NCT02052778-om-0012
source outcome index
12
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Scores at Specified Visits
measure definition
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patient-reported outcomes (PRO) Population that included all participants who had received TAS-120 treatment and had EQ-5D-3L assessment at Baseline and at least one subsequent post-baseline assessment. Here, 'number analyzed' = number of participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
qol key
qol-0013
source section id
NCT02052778-om-0013
source outcome index
13
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits
measure definition
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Usual Activities Scores at Specified Visits

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
qol key
qol-0014
source section id
NCT02052778-om-0014
source outcome index
14
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Usual Activities Scores at Specified Visits
measure definition
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Pain/Discomfort Scores at Specified Visits

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
qol key
qol-0015
source section id
NCT02052778-om-0015
source outcome index
15
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Pain/Discomfort Scores at Specified Visits
measure definition
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Anxiety/Depression Scores at Specified Visits

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
qol key
qol-0016
source section id
NCT02052778-om-0016
source outcome index
16
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Anxiety/Depression Scores at Specified Visits
measure definition
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Phase 2: Change From Baseline in EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
qol key
qol-0017
source section id
NCT02052778-om-0017
source outcome index
17
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Phase 2: Change From Baseline in EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits
measure definition
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A vertical VAS allows the participants to indicate their health state that day, and ranged from 0 (worst imaginable) to 100 (best imaginable), with higher scores indicating better health state.
time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating better
population note
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Phase 2:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score at Specified Timepoints

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
qol key
qol-0018
source section id
NCT02052778-om-0018
source outcome index
18
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Phase 2:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score at Specified Timepoints
measure definition
EORTC QLQ-C30 is a cancer-specific instrument that contains 30 questions for evaluation of new chemotherapy \& assessment of participant reported outcome. EORTC QLQ-C30 included global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 are 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale \& are 7-point scale (1/Very Poor to 7/Excellent). GHS total score is calculated as (\[{Q29+Q30}/2\]-1)/6\*100. Answers are converted into grading scale, with values between 0 (worse outcome) to100 (best outcome). High score represents a favorable outcome with best quality of life for participant.
time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-1aaa0cad
nct id
NCT02052778
trial label
A Study of TAS-120 in Patients With Advanced Solid Tumors
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
23
qol Count
7
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0000
    source section id
    NCT02052778-om-0000
    source outcome index
    0
    endpoint
    Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD)
    endpoint definition
    MTD:Highest dose level at which \<33% of participants experience dose-limiting toxicity (DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.
    time origin
    Cycle 1 (21-day cycle)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0001
    source section id
    NCT02052778-om-0001
    source outcome index
    1
    endpoint
    Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120
    endpoint definition
    RP2D was MTD or less. MTD: Highest dose level at which \<33% of participants experience DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.
    time origin
    Cycle 1 (21-day cycle)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    source section id
    NCT02052778-om-0002
    source outcome index
    2
    endpoint
    Phase 1: Dose Expansion: Percentage of Participants With Objective Response
    endpoint definition
    Objective response was defined as proportion of participants who had achieved best overall response of partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 millimeters (mm) and PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions. For Cohorts 1 to 6: Objective response was based on Independent Review Committee (IRC) and for pooled Sub-cohort: Objective response was based on investigator review.
    time origin
    Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy population included all participants who had received at least 1 dose of TAS-120. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1and 2.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0003
    source section id
    NCT02052778-om-0003
    source outcome index
    3
    endpoint
    Phase 2: Percentage of Participants With Objective Response
    endpoint definition
    Objective response was defined as proportion of participants who had achieved best overall response of PR or CR per RECIST v1.1. CR was defined as a disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 mm and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. The Phase 2 evaluation of objective response was based on central independent CT/MRI image assessment.
    time origin
    Up to approximately 37.5 months (through cut-off date 29-May-2021)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0004
    source section id
    NCT02052778-om-0004
    source outcome index
    4
    endpoint
    Phase 1: Dose Expansion: Duration of Response (DOR)
    endpoint definition
    A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. For Cohorts 1 to 6: DOR was based on IRC and for Group 3, 4, 5, 6 and for pooled Sub-cohort: DOR was based on investigator review.
    time origin
    Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohorts
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1 and 2.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0005
    source section id
    NCT02052778-om-0005
    source outcome index
    5
    endpoint
    Phase 2: Duration of Response (DOR)
    endpoint definition
    A DOR was defined as the time (in months) from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. Kaplan-Meier method was used for the analysis.
    time origin
    Up to approximately 37.5 months (through cut-off date 29-May-2021)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the subset of participants with PR or CR in efficacy population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Phase 1: Dose Escalation: QOD Dosing
    regimen
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 at 4 DLs from 8 to 36 mg orally every other day (QOD; Monday, Wednesday and Friday of each week) and participants with FGF/FGFR abnormalities received orally TAS-120 at 6 DLs from 56 mg to 240 mg QOD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 11 months).
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Phase 1: Dose Escalation: QD Dosing
    regimen
    Participants with or without FGF/FGFR gene abnormalities received a dose between 4 to 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 24 months).
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Phase 1: Dose Escalation: QOD Dosing
    regimen
    Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 at 4 DLs from 8 to 36 mg orally every other day (QOD; Monday, Wednesday and Friday of each week) and participants with FGF/FGFR abnormalities received orally TAS-120 at 6 DLs from 56 mg to 240 mg QOD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 11 months).
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Phase 1: Dose Escalation: QD Dosing
    regimen
    Participants with or without FGF/FGFR gene abnormalities received a dose between 4 to 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 24 months).
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Phase 1: Dose Expansion Cohort 1
    regimen
    Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Phase 1: Dose Expansion: Cohort 2
    regimen
    Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Phase 1: Dose Expansion: Cohort 3
    regimen
    Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Phase 1: Dose Expansion: Cohort 4
    regimen
    Participants with breast or gastric cancer with harboring FGFR2 amplification received TAS-120 20 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0002#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    arm key
    OG004
    arm label
    Phase 1: Dose Expansion: Cohort 5
    regimen
    Participants with tumor types harboring FGFR gene fusions or activating mutations received TAS-120 20 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0002#groups/OG004
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    arm key
    OG005
    arm label
    Phase 1: Dose Expansion: Cohort 6
    regimen
    Participants who were not included in Cohorts 1 to 5 received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0002#groups/OG005
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0002
    arm key
    OG006
    arm label
    Phase 1: Dose Expansion: Pooled Sub-cohort
    regimen
    Participants with iCCA and other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0002#groups/OG006
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Phase 2
    regimen
    Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    analyzed count
    103
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02052778-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG000
    source section id
    NCT02052778-ae
    event group key
    EG000
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 8 mg
    serious affected
    1
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG001
    source section id
    NCT02052778-ae
    event group key
    EG001
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 16 mg
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG002
    source section id
    NCT02052778-ae
    event group key
    EG002
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 24 mg
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG003
    source section id
    NCT02052778-ae
    event group key
    EG003
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 36 mg
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG004
    source section id
    NCT02052778-ae
    event group key
    EG004
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 56 mg
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG005
    source section id
    NCT02052778-ae
    event group key
    EG005
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 80 mg
    serious affected
    2
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG006
    source section id
    NCT02052778-ae
    event group key
    EG006
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 120 mg
    serious affected
    4
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG007
    source section id
    NCT02052778-ae
    event group key
    EG007
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 160 mg
    serious affected
    7
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG008
    source section id
    NCT02052778-ae
    event group key
    EG008
    event group label
    Phase 1: Dose Escalation: QOD Dosing: 200 mg
    serious affected
    4
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG009
    source section id
    NCT02052778-ae
    event group key
    EG009
    event group label
    Phase 1: Dose Escalation: QD Dosing: 4 mg
    serious affected
    0
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG010
    source section id
    NCT02052778-ae
    event group key
    EG010
    event group label
    Phase 1: Dose Escalation: QD Dosing: 8 mg
    serious affected
    1
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    harm key
    EG011
    source section id
    NCT02052778-ae
    event group key
    EG011
    event group label
    Phase 1: Dose Escalation: QD Dosing: 16 mg
    serious affected
    9
    serious at risk
    14
    other affected
    14
    other at risk
    14
    frequency threshold
    5
    collection period
    From the first dose administration up to approximately up to 59.5 months for Phase 1 Dose escalation; up to 50.5 months for Phase 1 Dose expansion Cohorts and up to 37.5 months for Phase 2
    event definition
    Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    qol key
    qol-0012
    source section id
    NCT02052778-om-0012
    source outcome index
    12
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Scores at Specified Visits
    measure definition
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    time frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Patient-reported outcomes (PRO) Population that included all participants who had received TAS-120 treatment and had EQ-5D-3L assessment at Baseline and at least one subsequent post-baseline assessment. Here, 'number analyzed' = number of participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    qol key
    qol-0013
    source section id
    NCT02052778-om-0013
    source outcome index
    13
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits
    measure definition
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    time frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    qol key
    qol-0014
    source section id
    NCT02052778-om-0014
    source outcome index
    14
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Usual Activities Scores at Specified Visits
    measure definition
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    time frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    qol key
    qol-0015
    source section id
    NCT02052778-om-0015
    source outcome index
    15
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Pain/Discomfort Scores at Specified Visits
    measure definition
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    time frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    qol key
    qol-0016
    source section id
    NCT02052778-om-0016
    source outcome index
    16
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Anxiety/Depression Scores at Specified Visits
    measure definition
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
    time frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    qol key
    qol-0017
    source section id
    NCT02052778-om-0017
    source outcome index
    17
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Phase 2: Change From Baseline in EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits
    measure definition
    EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A vertical VAS allows the participants to indicate their health state that day, and ranged from 0 (worst imaginable) to 100 (best imaginable), with higher scores indicating better health state.
    time frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores indicating better
    population note
    Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-tecentriq-1aaa0cad
    nct id
    NCT02052778
    qol key
    qol-0018
    source section id
    NCT02052778-om-0018
    source outcome index
    18
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Phase 2:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score at Specified Timepoints
    measure definition
    EORTC QLQ-C30 is a cancer-specific instrument that contains 30 questions for evaluation of new chemotherapy \& assessment of participant reported outcome. EORTC QLQ-C30 included global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 are 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale \& are 7-point scale (1/Very Poor to 7/Excellent). GHS total score is calculated as (\[{Q29+Q30}/2\]-1)/6\*100. Answers are converted into grading scale, with values between 0 (worse outcome) to100 (best outcome). High score represents a favorable outcome with best quality of life for participant.
    time frame
    Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice