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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.

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
    FG000
    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
    FG001
    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
    FG002
    title
    Metastatic CRC Cohort
  4. 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 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
    id
    FG003
    title
    sqEC Cohort
  5. 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 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
    id
    FG004
    title
    sqNSCLC Cohort
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        8
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      type
      Site Terminated by Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study had two parts, Part 1 (Safety Cohort) enrolled western participants with locally advanced/metastatic solid tumors to receive TAK-931 and assessed safety, tolerability and pharmacokinetics. In Part 2, participants were enrolled into Tumor (Disease)-Specific Cohorts based on tumor criteria: pancreatic cancer, metastatic colorectal cancer (CRC), squamous esophageal cancer (sqEC), squamous non-small-cell lung cancer (sqNSCLC) to receive TAK-931 and were assessed for antitumor activity.
recruitment Details
Participants took part in the study at 12 investigative sites in Japan and the United States from 25 October 2017 to 24 August 2020.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    title
    Metastatic CRC Cohort
  4. 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 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
    id
    FG003
    title
    sqEC Cohort
  5. 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 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
    id
    FG004
    title
    sqNSCLC Cohort
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        8
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      type
      Site Terminated by Sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study had two parts, Part 1 (Safety Cohort) enrolled western participants with locally advanced/metastatic solid tumors to receive TAK-931 and assessed safety, tolerability and pharmacokinetics. In Part 2, participants were enrolled into Tumor (Disease)-Specific Cohorts based on tumor criteria: pancreatic cancer, metastatic colorectal cancer (CRC), squamous esophageal cancer (sqEC), squamous non-small-cell lung cancer (sqNSCLC) to receive TAK-931 and were assessed for antitumor activity.
recruitment Details
Participants took part in the study at 12 investigative sites in Japan and the United States from 25 October 2017 to 24 August 2020.

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Preserved source evidence · Not medical advice