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NCT04737187 · FLOW

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Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients · Source last updated 2024-09-24

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

groups
  1. description
    Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram \[mg/kg\], intravenous \[IV\] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
    id
    FG000
    title
    Trifluridine/Tipiracil + Bevacizumab
  2. description
    Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
    id
    FG001
    title
    Trifluridine/Tipiracil
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        4
      type
      Switched to marketed drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        145
      2. group Id
        FG001
        num Subjects
        146
      type
      Radiological Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        20
      type
      Clinical Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        52
      type
      Radiological And Clinical Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        246
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        246
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomization (1:1 ratio): stratified by geographic region (North America, European Union, Rest of the World), time since 1st metastasis diagnosis (less than \[\<\] 18 months, greater than or equal to \[\>=\] 18 months) and rat sarcoma virus status (wild-type, mutant). Primary analysis of overall survival as primary outcome measure was completed with cutoff date of July 19, 2022; no efficacy analysis was conducted after this cutoff and participants were continued to be followed for safety analysis.
recruitment Details
The study was conducted at 99 active sites in 13 countries. A total of 659 participants were screened, of which 492 participants were randomized and treated.
Complete source fields
groups
  1. description
    Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram \[mg/kg\], intravenous \[IV\] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
    id
    FG000
    title
    Trifluridine/Tipiracil + Bevacizumab
  2. description
    Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
    id
    FG001
    title
    Trifluridine/Tipiracil
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        4
      type
      Switched to marketed drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        145
      2. group Id
        FG001
        num Subjects
        146
      type
      Radiological Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        20
      type
      Clinical Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        52
      type
      Radiological And Clinical Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        246
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        246
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomization (1:1 ratio): stratified by geographic region (North America, European Union, Rest of the World), time since 1st metastasis diagnosis (less than \[\<\] 18 months, greater than or equal to \[\>=\] 18 months) and rat sarcoma virus status (wild-type, mutant). Primary analysis of overall survival as primary outcome measure was completed with cutoff date of July 19, 2022; no efficacy analysis was conducted after this cutoff and participants were continued to be followed for safety analysis.
recruitment Details
The study was conducted at 99 active sites in 13 countries. A total of 659 participants were screened, of which 492 participants were randomized and treated.

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Preserved source evidence · Independent clinical review pending · Not medical advice