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NCT03261947 · OUTCOME

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931

A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors · Source last updated 2021-09-20

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

Measure
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Analysis population: PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Groups in this outcome

Western Safety Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.

Pancreatic Cancer Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.

Metastatic CRC Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.

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

Analysis denominator · Participants

GroupSource count
Western Safety Cohort12
Pancreatic Cancer Cohort15
Metastatic CRC Cohort34

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Western Safety Cohort12
Pancreatic Cancer Cohort12
Metastatic CRC Cohort13
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Western Safety Cohort1.57Not reported0.82.2Not reported
Pancreatic Cancer Cohort2.00Not reported0.56.3Not reported
Metastatic CRC Cohort1.85Not reported0.96.0Not reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Western Safety Cohort12
Pancreatic Cancer Cohort10
Metastatic CRC Cohort11
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Western Safety Cohort1.59Not reported1.04.0Not reported
Pancreatic Cancer Cohort2.00Not reported1.04.3Not reported
Metastatic CRC Cohort1.97Not reported1.04.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        2.2
        value
        1.57
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        6.3
        value
        2.00
      3. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        6.0
        value
        1.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        13
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        4.0
        value
        1.59
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        4.3
        value
        2.00
      3. group Id
        OG002
        lower Limit
        1.0
        upper Limit
        4.0
        value
        1.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Cycle 1 Day 8
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      34
    units
    Participants
dispersion Type
Full Range
groups
  1. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
    id
    OG000
    title
    Western Safety Cohort
  2. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
    id
    OG001
    title
    Pancreatic Cancer Cohort
  3. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
    id
    OG002
    title
    Metastatic CRC Cohort
param Type
MEDIAN
population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.
reporting Status
POSTED
time Frame
Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
title
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931
type
SECONDARY
unit Of Measure
hour

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice