Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02287233 · OUTCOME

Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to Last Measurable Concentration (AUCt) 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
MEAN
Unit
ng*h/mL
Interval / dispersion
Standard Deviation
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.

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 ng*h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC19466.3Not reportedNot reportedNot reported
Phase 1: 800 mg Venetoclax + LDAC20462.9Not reportedNot reportedNot reported
Cycle 1, Day 10 (LDAC with Venetoclax)
Values in ng*h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: 600 mg Venetoclax + LDAC23189.0Not reportedNot reportedNot reported
Phase 1: 800 mg Venetoclax + LDAC20254.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        66.3
        value
        194
      2. group Id
        OG001
        spread
        62.9
        value
        204
    title
    Cycle 1, Day 1 (LDAC Alone)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.0
        value
        231
      2. group Id
        OG001
        spread
        54.9
        value
        202
    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
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 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: Area Under the Plasma Concentration-Time Curve Over Time From 0 to Last Measurable Concentration (AUCt) of Cytarabine
type
PRIMARY
unit Of Measure
ng*h/mL

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

Preserved source evidence · Not medical advice