Trial Condition(s):

Leukemia, Myeloid, Acute

BAY1436032 in patients with mutant IDH1(mIDH1) advanced acute myeloid leukemia (AML)

Bayer Identifier:

19036

ClinicalTrials.gov Identifier:

NCT03127735

EudraCT Number:

2016-004095-22

Study Completed

Trial Purpose

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)

Inclusion Criteria
- Patients with advanced AML that harbors IDH1 mutation
- Patients are relapsed from or refractory to at least 1 previous line of therapy
- Good kidney and liver function
- Male or female patients
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal
Exclusion Criteria
- Previously treated with any prior mIDH1 targeted therapy
- Extramedullary disease only
- History of clinically significant or active cardiac disease
- Active clinically significant infection
- Unresolved chronic toxicity of previous AML treatment
- Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors
- Pregnancy or breast-feeding

Trial Summary

Enrollment Goal
27
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1436032
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Status
Completed
 
Locations

Ohio State University

Columbus, United States, 43210

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany

Status
Completed
 
Locations

Roswell Park Comprehensive Cancer Center

Buffalo, United States, 14263-0001

Status
Completed
 
Locations

Montefiore Medical Center

Bronx, United States, 10467-2490

Status
Completed
 
Locations

Wake Forest Baptist Health

Winston-Salem, United States, 27157

Status
Completed
 
Locations

University of Pennsylvania

Philadelphia, United States, 19104

Status
Completed
 
Locations

Mount Sinai Medical Center

New York, United States, 10029

Status
Completed
 
Locations

Medizinische Hochschule Hannover (MHH)

Hannover, Germany, 30625

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Universitätsklinikum Charite zu Berlin

Berlin, Germany, 12200

Status
Completed
 
Locations

Thomas Jefferson University

Philadelphia, United States, 19107

Status
Completed
 

Trial Design