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NCT02347917 · OUTCOME

Response Rate (RR) and Disease Control Rate (DCR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From BBI608 administration to death from any cause, about 17 months

What was measured

Response rate (RR): Proportion of subjects whose best overall response is CR or PR. Disease control rate (DCR): Proportion of subjects whose best overall response is CR, PR or SD. The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.

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

Response rate (RR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)0Not reportedNot reportedNot reportedNot reported
MPM: BBI608 + Pem +CDDP (Phase 1 Part)0Not reportedNot reportedNot reportedNot reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)0Not reportedNot reportedNot reportedNot reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)8Not reportedNot reportedNot reportedNot reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)8Not reportedNot reportedNot reportedNot reported
Disease control rate (DCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)3Not reportedNot reportedNot reportedNot reported
MPM: BBI608 + Pem +CDDP (Phase 1 Part)0Not reportedNot reportedNot reportedNot reported
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)3Not reportedNot reportedNot reportedNot reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part)19Not reportedNot reportedNot reportedNot reported
MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        8
    title
    Response rate (RR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        19
    title
    Disease control rate (DCR)
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
Response rate (RR): Proportion of subjects whose best overall response is CR or PR. Disease control rate (DCR): Proportion of subjects whose best overall response is CR, PR or SD. The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.
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
COUNT_OF_PARTICIPANTS
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, about 17 months
title
Response Rate (RR) and Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice