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NCT02052778 · OUTCOME

Phase 1: Dose Expansion: Percentage of Participants With Objective Response

A Study of TAS-120 in Patients With Advanced Solid Tumors · Source last updated 2025-03-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
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

What was measured

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.

Analysis population: 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.

Groups in this outcome

Phase 1: Dose Expansion Cohort 1

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

Phase 1: Dose Expansion: Cohort 2

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.

Phase 1: Dose Expansion: Cohort 3

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.

Phase 1: Dose Expansion: Cohort 4

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.

Phase 1: Dose Expansion: Cohort 5

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.

Phase 1: Dose Expansion: Cohort 6

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.

Phase 1: Dose Expansion: Pooled Sub-cohort

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1: Dose Expansion Cohort 157
Phase 1: Dose Expansion: Cohort 234
Phase 1: Dose Expansion: Cohort 315
Phase 1: Dose Expansion: Cohort 413
Phase 1: Dose Expansion: Cohort 524
Phase 1: Dose Expansion: Cohort 627
Phase 1: Dose Expansion: Pooled Sub-cohort27

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: Dose Expansion Cohort 115.8Not reported7.527.9Not reported
Phase 1: Dose Expansion: Cohort 28.8Not reported1.923.7Not reported
Phase 1: Dose Expansion: Cohort 313.3Not reported1.740.5Not reported
Phase 1: Dose Expansion: Cohort 40Not reported0.024.7Not reported
Phase 1: Dose Expansion: Cohort 512.5Not reported2.732.4Not reported
Phase 1: Dose Expansion: Cohort 60Not reported0.012.8Not reported
Phase 1: Dose Expansion: Pooled Sub-cohort33.3Not reported16.554.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.5
        upper Limit
        27.9
        value
        15.8
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        23.7
        value
        8.8
      3. group Id
        OG002
        lower Limit
        1.7
        upper Limit
        40.5
        value
        13.3
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        24.7
        value
        0
      5. group Id
        OG004
        lower Limit
        2.7
        upper Limit
        32.4
        value
        12.5
      6. group Id
        OG005
        lower Limit
        0.0
        upper Limit
        12.8
        value
        0
      7. group Id
        OG006
        lower Limit
        16.5
        upper Limit
        54.0
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    2. group Id
      OG001
      value
      34
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      13
    5. group Id
      OG004
      value
      24
    6. group Id
      OG005
      value
      27
    7. group Id
      OG006
      value
      27
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    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
    id
    OG000
    title
    Phase 1: Dose Expansion Cohort 1
  2. description
    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.
    id
    OG001
    title
    Phase 1: Dose Expansion: Cohort 2
  3. description
    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.
    id
    OG002
    title
    Phase 1: Dose Expansion: Cohort 3
  4. description
    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.
    id
    OG003
    title
    Phase 1: Dose Expansion: Cohort 4
  5. description
    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.
    id
    OG004
    title
    Phase 1: Dose Expansion: Cohort 5
  6. description
    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.
    id
    OG005
    title
    Phase 1: Dose Expansion: Cohort 6
  7. description
    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.
    id
    OG006
    title
    Phase 1: Dose Expansion: Pooled Sub-cohort
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
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
title
Phase 1: Dose Expansion: Percentage of Participants With Objective Response
type
PRIMARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice