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Mutant IDH1 Inhibitor

BAY1436032 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hour post-dose (each cycle is 28 days)
Awards & highlights
No Placebo-Only Group

Summary

To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hour post-dose (each cycle is 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hour post-dose (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) or RP2D of BAY1436032
Number of participants with Adverse Events as a Measure of
Secondary study objectives
AUC(0-12) (AUC from time 0 to 12 h after a single dose)
AUC(0-12)md (AUC from time 0 to 12 h after multiple doses)
AUC(0-8) (AUC from time 0 to 8 h after a single dose)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BAY1436032Experimental Treatment1 Intervention
Dose escalation: Various doses of study drug will be tested on a small number of patients/dose with the goal of identifying the most appropriate dose(s) for further evaluation in dose expansion. The MTD of the study drug may or may not be identified. It is anticipated that 3-4 patients will be treated at each dose of study drug to be tested and that 15-20 total patients will be treated in this part of the trial. Dose expansion: Up to 2 different doses of study drug will be tested on up to 30 patients/dose with the goal of identifying the most appropriate RP2D for further clinical development. The doses to be evaluated in this part of the trial will be selected based on information obtained during dose escalation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY1436032
2017
Completed Phase 1
~30

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Who is running the clinical trial?

BayerLead Sponsor
2,270 Previous Clinical Trials
25,508,705 Total Patients Enrolled
~3 spots leftby Oct 2025
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