Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02287233 · OUTCOME

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
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 time at which the maximum plasma concentration (Cmax) is observed.

Analysis population: Participants enrolled in Phase 1 who had at least one dose of venetoclax 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 10 (Venetoclax with LDAC)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC4.0Not reported4.06.0Not reported
Phase 1: 800 mg Venetoclax + LDAC8.0Not reported4.08.0Not reported
Cycle 1, Day 18 (Venetoclax Alone)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC7.0Not reported3.58.0Not reported
Phase 1: 800 mg Venetoclax + LDAC6.6Not reported4.08.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.0
        upper Limit
        6.0
        value
        4.0
      2. group Id
        OG001
        lower Limit
        4.0
        upper Limit
        8.0
        value
        8.0
    title
    Cycle 1, Day 10 (Venetoclax with LDAC)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.5
        upper Limit
        8.0
        value
        7.0
      2. group Id
        OG001
        lower Limit
        4.0
        upper Limit
        8.0
        value
        6.6
    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 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 venetoclax and had at least one reported 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: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
type
PRIMARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice