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NCT02347917 · OUTCOME

Phase 1 Part: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of BBI608 When Administered With Pem and CDDP

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
MEAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1 (Cmax only) and Day 23

Analysis population: Pharmacokinetic (PK) analysis population 1 participant with MPM of 4 participants in the pharmacokinetic analysis population completed BBI608 administration on Day 14 in Cycle 1 and therefore was not included in the analysis for Cmax and AUC on Day 23.

Groups in this outcome

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.

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

Analysis denominator · Participants

GroupSource count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)4

Reported measurements

Day 1: Cmax

Analysis denominator · Participants

GroupSource count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)4
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)307.5Not reported251380Not reported
Day 23: Cmax

Analysis denominator · Participants

GroupSource count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)3
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)473.7Not reported316643Not reported
Day 23: Cmin

Analysis denominator · Participants

GroupSource count
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)3
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)196.1Not reported30.4392.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        251
        upper Limit
        380
        value
        307.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 1: Cmax
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        316
        upper Limit
        643
        value
        473.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Day 23: Cmax
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.4
        upper Limit
        392.0
        value
        196.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Day 23: Cmin
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
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
    MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)
param Type
MEAN
population Description
Pharmacokinetic (PK) analysis population 1 participant with MPM of 4 participants in the pharmacokinetic analysis population completed BBI608 administration on Day 14 in Cycle 1 and therefore was not included in the analysis for Cmax and AUC on Day 23.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (Cmax only) and Day 23
title
Phase 1 Part: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of BBI608 When Administered With Pem and CDDP
type
PRIMARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice