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

ID#: NCT03127735

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: June 14, 2017

End Date: October 11, 2019

Contact Information:
Bayer Clinical Trials Contact
(+) 1-888-8422937
For trial location information (Phone Menu Options '3' or '4')
(+)1-888-84 22937

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