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NCT02287233 · OUTCOME

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Cytarabine

A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia · Source last updated 2022-08-29

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose.

What was measured

The time at which the maximum plasma concentration (Cmax) is observed.

Analysis population: Participants enrolled in Phase 1 who had at least one dose of cytarabine and had at least one reported PK sample concentration.

Groups in this outcome

Phase 1: 600 mg Venetoclax + LDAC

Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Phase 1: 800 mg Venetoclax + LDAC

Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

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

Analysis denominator · Participants

GroupSource count
Phase 1: 600 mg Venetoclax + LDAC7
Phase 1: 800 mg Venetoclax + LDAC10

Reported measurements

Cycle 1, Day 1 (LDAC Alone)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC0.3Not reported0.30.4Not reported
Phase 1: 800 mg Venetoclax + LDAC0.3Not reported0.20.5Not reported
Cycle 1, Day 10 (LDAC with Venetoclax)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC0.3Not reported0.30.5Not reported
Phase 1: 800 mg Venetoclax + LDAC0.3Not reported0.20.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        0.4
        value
        0.3
      2. group Id
        OG001
        lower Limit
        0.2
        upper Limit
        0.5
        value
        0.3
    title
    Cycle 1, Day 1 (LDAC Alone)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        0.5
        value
        0.3
      2. group Id
        OG001
        lower Limit
        0.2
        upper Limit
        0.5
        value
        0.3
    title
    Cycle 1, Day 10 (LDAC with Venetoclax)
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      10
    units
    Participants
description
The time at which the maximum plasma concentration (Cmax) is observed.
dispersion Type
Full Range
groups
  1. description
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
    id
    OG000
    title
    Phase 1: 600 mg Venetoclax + LDAC
  2. description
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
    id
    OG001
    title
    Phase 1: 800 mg Venetoclax + LDAC
param Type
MEDIAN
population Description
Participants enrolled in Phase 1 who had at least one dose of cytarabine and had at least one reported PK sample concentration.
reporting Status
POSTED
time Frame
Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose.
title
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Cytarabine
type
PRIMARY
unit Of Measure
hours

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice