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NCT02052778 · OUTCOME

Phase 1: Dose Expansion: Overall Survival (OS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
up to approximately 27.5 months (through cut-off date 30-Jun-2019)

What was measured

An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.

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 1 and 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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: Dose Expansion Cohort 111.4Not reported8.115.1Not reported
Phase 1: Dose Expansion: Cohort 211.8Not reported5.5NAUpper limit of 95% confidence interval (CI) was not estimable due to the smaller number of participants with events.
Phase 1: Dose Expansion: Cohort 38.6Not reported2.1NAUpper limit of 95% CI was not estimable due to the smaller number of participants with events.
Phase 1: Dose Expansion: Cohort 45.8Not reported4.6NAUpper limit of 95% CI was not estimable due to the smaller number of participants with events.
Phase 1: Dose Expansion: Cohort 510.5Not reported6.7NAUpper limit of 95% CI was not estimable due to the smaller number of participants with events.
Phase 1: Dose Expansion: Cohort 67.2Not reported5.6NAUpper limit of 95% CI was not estimable due to the smaller number of participants with events.
Phase 1: Dose Expansion: Pooled Sub-cohortNANot reported12.2NAMedian and upper limit of 95% CI was not estimable due to the smaller number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.1
        upper Limit
        15.1
        value
        11.4
      2. comment
        Upper limit of 95% confidence interval (CI) was not estimable due to the smaller number of participants with events.
        group Id
        OG001
        lower Limit
        5.5
        upper Limit
        NA
        value
        11.8
      3. comment
        Upper limit of 95% CI was not estimable due to the smaller number of participants with events.
        group Id
        OG002
        lower Limit
        2.1
        upper Limit
        NA
        value
        8.6
      4. comment
        Upper limit of 95% CI was not estimable due to the smaller number of participants with events.
        group Id
        OG003
        lower Limit
        4.6
        upper Limit
        NA
        value
        5.8
      5. comment
        Upper limit of 95% CI was not estimable due to the smaller number of participants with events.
        group Id
        OG004
        lower Limit
        6.7
        upper Limit
        NA
        value
        10.5
      6. comment
        Upper limit of 95% CI was not estimable due to the smaller number of participants with events.
        group Id
        OG005
        lower Limit
        5.6
        upper Limit
        NA
        value
        7.2
      7. comment
        Median and upper limit of 95% CI was not estimable due to the smaller number of participants with events.
        group Id
        OG006
        lower Limit
        12.2
        upper Limit
        NA
        value
        NA
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
An OS was defined as the time (in months) from the date of the first dose to the death date. In the absence of death confirmation or for participants alive as of the OS cut-off date, survival time was censored at the date of last study follow-up, or the cut-off date, whichever was earlier.
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
MEDIAN
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 1 and 2.
reporting Status
POSTED
time Frame
up to approximately 27.5 months (through cut-off date 30-Jun-2019)
title
Phase 1: Dose Expansion: Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice