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NCT02287233 · OUTCOME

Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax

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
MEAN
Unit
µg*h/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)

Analysis population: Participants enrolled in Phase 1 who had at least one dose of venetoclax and had at least one reported PK sample concentration with available data at each time point

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 10 (Venetoclax with LDAC)

Analysis denominator · Participants

GroupSource count
Phase 1: 600 mg Venetoclax + LDAC7
Phase 1: 800 mg Venetoclax + LDAC10
Values in µg*h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC33.327.5Not reportedNot reportedNot reported
Phase 1: 800 mg Venetoclax + LDAC33.414.1Not reportedNot reportedNot reported
Cycle 1, Day 18 (Venetoclax Alone)

Analysis denominator · Participants

GroupSource count
Phase 1: 600 mg Venetoclax + LDAC6
Phase 1: 800 mg Venetoclax + LDAC9
Values in µg*h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC51.836.9Not reportedNot reportedNot reported
Phase 1: 800 mg Venetoclax + LDAC35.419.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.5
        value
        33.3
      2. group Id
        OG001
        spread
        14.1
        value
        33.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Cycle 1, Day 10 (Venetoclax with LDAC)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.9
        value
        51.8
      2. group Id
        OG001
        spread
        19.8
        value
        35.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Cycle 1, Day 18 (Venetoclax Alone)
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      10
    units
    Participants
dispersion Type
Standard Deviation
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
MEAN
population Description
Participants enrolled in Phase 1 who had at least one dose of venetoclax and had at least one reported PK sample concentration with available data at each time point
reporting Status
POSTED
time Frame
Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)
title
Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax
type
PRIMARY
unit Of Measure
µg*h/mL

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

Preserved source evidence · Not medical advice