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NCT02287233 · OUTCOME

Phase 1: Maximum Observed Plasma Concentration (Cmax) 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/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)

What was measured

The highest concentration that a drug achieves in the blood after administration in a dosing interval.

Analysis population: Participants enrolled in Phase 1 who had at least one dose of venetoclax and had at least one reported pharmacokinetic (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 10 (Venetoclax with LDAC)
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC2.041.45Not reportedNot reportedNot reported
Phase 1: 800 mg Venetoclax + LDAC2.260.930Not reportedNot reportedNot reported
Cycle 1, Day 18 (Venetoclax alone)
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC2.922.15Not reportedNot reportedNot reported
Phase 1: 800 mg Venetoclax + LDAC2.361.22Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.45
        value
        2.04
      2. group Id
        OG001
        spread
        0.930
        value
        2.26
    title
    Cycle 1, Day 10 (Venetoclax with LDAC)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.15
        value
        2.92
      2. group Id
        OG001
        spread
        1.22
        value
        2.36
    title
    Cycle 1, Day 18 (Venetoclax alone)
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      10
    units
    Participants
description
The highest concentration that a drug achieves in the blood after administration in a dosing interval.
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 pharmacokinetic (PK) sample concentration.
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: Maximum Observed Plasma Concentration (Cmax) of Venetoclax
type
PRIMARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice