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Completed Phase 1 Interventional

BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)

ClinicalTrials.gov ID: NCT03127735

Public ClinicalTrials.gov record NCT03127735. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 7:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Non-randomized, Multicenter Phase I Study 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)

Study identification

NCT ID
NCT03127735
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Bayer
Industry
Enrollment
27 participants

Conditions and interventions

Interventions

  • BAY1436032 Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 13, 2017
Primary completion
Dec 5, 2018
Completion
Mar 14, 2019
Last update posted
May 13, 2019

2017 – 2019

United States locations

U.S. sites
8
U.S. states
5
U.S. cities
7
Facility City State ZIP Site status
Roswell Park Comprehensive Cancer Center Buffalo New York 14263-0001
Mount Sinai Medical Center New York New York 10029
Montefiore Medical Center The Bronx New York 10467-2490
Wake Forest Baptist Health Winston-Salem North Carolina 27157
Ohio State University Columbus Ohio 43210
University of Pennsylvania Philadelphia Pennsylvania 19104
Thomas Jefferson University Philadelphia Pennsylvania 19107
University of Texas MD Anderson Cancer Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03127735, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2019 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03127735 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →