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NCT02347917 · OUTCOME

Overall Survival(OS)

A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma · Source last updated 2022-04-12

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

Measure
MEDIAN
Unit
month
Interval / dispersion
Full Range
Time frame
From BBI608 administration to death from any cause, up to 31 months

What was measured

OS was defined as the time from BBI608 administration to death from any cause. Participants alive at final observation or lost to follow-up were censored at their last contact (i.e., visit or telephone) date.

Analysis population: modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25).

Groups in this outcome

NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

MPM: BBI608 + Pem +CDDP (Phase 1 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

MPM: BBI608 + Pem + CDDP (Phase 2 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)

Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.

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

Analysis denominator · Participants

GroupSource count
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)3
MPM: BBI608 + Pem +CDDP (Phase 1 Part)1
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)4
MPM: BBI608 + Pem + CDDP (Phase 2 Part)24
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)25

Reported measurements

Source class 1
Values in month · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)19.81Not reported19.427.8Not reported
MPM: BBI608 + Pem +CDDP (Phase 1 Part)30.1Not reported30.130.1Not reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)NANot reported19.430.1Not calculated for total population in Phase 1 part because calculated for each cancer type (i.e., NSCLC and MPM separately)
MPM: BBI608 + Pem + CDDP (Phase 2 Part)12.14Not reported3.028.6Not reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)12.75Not reported3.030.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.4
        upper Limit
        27.8
        value
        19.81
      2. group Id
        OG001
        lower Limit
        30.1
        upper Limit
        30.1
        value
        30.1
      3. comment
        Not calculated for total population in Phase 1 part because calculated for each cancer type (i.e., NSCLC and MPM separately)
        group Id
        OG002
        lower Limit
        19.4
        upper Limit
        30.1
        value
        NA
      4. group Id
        OG003
        lower Limit
        3.0
        upper Limit
        28.6
        value
        12.14
      5. group Id
        OG004
        lower Limit
        3.0
        upper Limit
        30.1
        value
        12.75
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      24
    5. group Id
      OG004
      value
      25
    units
    Participants
description
OS was defined as the time from BBI608 administration to death from any cause. Participants alive at final observation or lost to follow-up were censored at their last contact (i.e., visit or telephone) date.
dispersion Type
Full Range
groups
  1. description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    OG000
    title
    NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
  2. description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    OG001
    title
    MPM: BBI608 + Pem +CDDP (Phase 1 Part)
  3. description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    OG002
    title
    MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
  4. description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    OG003
    title
    MPM: BBI608 + Pem + CDDP (Phase 2 Part)
  5. description
    Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles. Premeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.
    id
    OG004
    title
    MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)
param Type
MEDIAN
population Description
modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25).
reporting Status
POSTED
time Frame
From BBI608 administration to death from any cause, up to 31 months
title
Overall Survival(OS)
type
SECONDARY
unit Of Measure
month

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Preserved source evidence · Not medical advice