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NCT03710876 · FLOW

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Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma · Source last updated 2026-04-21

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

groups
  1. description
    rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    FG000
    title
    Treatment Group
  2. description
    Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    FG001
    title
    Control Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        22
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        22
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study opened to recruitment in January 2019 and was scheduled to complete recruitment by May 2021, with a target of approximately 300. 53 patients were randomized to treatment.
Complete source fields
groups
  1. description
    rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    FG000
    title
    Treatment Group
  2. description
    Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    FG001
    title
    Control Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        22
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        22
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study opened to recruitment in January 2019 and was scheduled to complete recruitment by May 2021, with a target of approximately 300. 53 patients were randomized to treatment.

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

Preserved source evidence · Not medical advice