NCT02601209 · STUDY IN CONTEXT

Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

The Maximum Tolerated Dose (MTD) of sapanisertib (MLN0128) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event is reported.

Phase I

→

primary · POSTED

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods.

Phase II Analysis Group 2 - Initial Treatment Period

→

secondary · POSTED

The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below.

Phase II Analysis Group 2 - Initial Treatment Period; This analysis excludes cancel patients (who never received treatment i.e. Withdrew before initiation of regimen )

→

secondary · POSTED

The frequencies (and percentages) of tumor response categories (CR, PR, SD, PD) will be summarized for Phase II Analysis Group 2. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.

Phase II Analysis Group 2 - Initial Treatment Period; Patients with tumor response data available are included in this analysis.

→

secondary · POSTED

Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD.

Phase II Analysis Group 2 - Initial Treatment Period; Only patients that had a complete response or partial response are included in this analysis.

→

secondary · POSTED

Will be defined as the number of patients having either complete response (CR), partial response (PR), or stable disease for at least 6 months after starting treatment. The frequencies and rates of tumor response categories (CR, PR, SD, PD, and too early/not evaluated) will be summarized by dose cohort and treatment arm. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.

Phase II Analysis Group 2 - Initial Treatment Period

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-fibrosarcoma
nct id: NCT02601209
trial label: Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0000
source section id
NCT02601209-om-0000
source outcome index
0
endpoint
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
endpoint definition
The Maximum Tolerated Dose (MTD) of sapanisertib (MLN0128) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event is reported.
time origin
28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase I
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0001
source section id
NCT02601209-om-0001
source outcome index
1
endpoint
Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period)
endpoint definition
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods.
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase II Analysis Group 2 - Initial Treatment Period
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0002
source section id
NCT02601209-om-0002
source outcome index
2
endpoint
The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period)
endpoint definition
The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below.
time origin
Up to 4 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Phase II Analysis Group 2 - Initial Treatment Period; This analysis excludes cancel patients (who never received treatment i.e. Withdrew before initiation of regimen )
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0003
source section id
NCT02601209-om-0003
source outcome index
3
endpoint
Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period)
endpoint definition
The frequencies (and percentages) of tumor response categories (CR, PR, SD, PD) will be summarized for Phase II Analysis Group 2. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Phase II Analysis Group 2 - Initial Treatment Period; Patients with tumor response data available are included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0004
source section id
NCT02601209-om-0004
source outcome index
4
endpoint
Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period)
endpoint definition
Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD.
time origin
Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Phase II Analysis Group 2 - Initial Treatment Period; Only patients that had a complete response or partial response are included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0005
source section id
NCT02601209-om-0005
source outcome index
5
endpoint
Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period)
endpoint definition
Will be defined as the number of patients having either complete response (CR), partial response (PR), or stable disease for at least 6 months after starting treatment. The frequencies and rates of tumor response categories (CR, PR, SD, PD, and too early/not evaluated) will be summarized by dose cohort and treatment arm. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.
time origin
Up to 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Phase II Analysis Group 2 - Initial Treatment Period
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0000
arm key
OG000
arm label
Phase I - Dose Level 0
regimen
Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0000
arm key
OG001
arm label
Phase I - Dose Level 1
regimen
Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0000
arm key
OG002
arm label
Phase I - Dose Level 2
regimen
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0001
arm key
OG000
arm label
Phase II - Analysis Group 2 MLN0128
regimen
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
analyzed count
56
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0001
arm key
OG001
arm label
Phase II - Analysis Group 2 Pazopanib
regimen
Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0002
arm key
OG000
arm label
Phase II - Analysis Group 2 MLN0128
regimen
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
analyzed count
55
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0002
arm key
OG001
arm label
Phase II - Analysis Group 2 Pazopanib
regimen
Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
analyzed count
56
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0003
arm key
OG000
arm label
Phase II - Analysis Group 2 MLN0128
regimen
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0003
arm key
OG001
arm label
Phase II - Analysis Group 2 Pazopanib
regimen
Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
analyzed count
51
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0004
arm key
OG000
arm label
Phase II - Analysis Group 2 MLN0128
regimen
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0004
arm key
OG001
arm label
Phase II - Analysis Group 2 Pazopanib
regimen
Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
outcome key
om-0005
arm key
OG000
arm label
Phase II - Analysis Group 2 MLN0128
regimen
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
analyzed count
56
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601209-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
harm key
EG000
source section id
NCT02601209-ae
event group key
EG000
event group label
Phase I - Dose Level 0
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
harm key
EG001
source section id
NCT02601209-ae
event group key
EG001
event group label
Phase I - Dose Level 1
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
harm key
EG002
source section id
NCT02601209-ae
event group key
EG002
event group label
Phase I - Dose Level 2
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
harm key
EG003
source section id
NCT02601209-ae
event group key
EG003
event group label
Phase II - Analysis Group 1 MLN0128
serious affected
5
serious at risk
12
other affected
12
other at risk
12
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
harm key
EG004
source section id
NCT02601209-ae
event group key
EG004
event group label
Phase II - Analysis Group 1 Pazopanib
serious affected
6
serious at risk
12
other affected
12
other at risk
12
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
harm key
EG005
source section id
NCT02601209-ae
event group key
EG005
event group label
Phase II - Analysis Group 2 MLN0128
serious affected
20
serious at risk
55
other affected
54
other at risk
55
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-fibrosarcoma
nct id
NCT02601209
harm key
EG006
source section id
NCT02601209-ae
event group key
EG006
event group label
Phase II - Analysis Group 2 Pazopanib
serious affected
24
serious at risk
56
other affected
55
other at risk
56
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
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

setting source links

Preserved source evidence · Not medical advice