BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | June 14, 2017 |
| End Date: | March 15, 2019 |
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)
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)
(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
We found this trial at
9
sites
Click here to add this to my saved trials
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
Click here to add this to my saved trials
Click here to add this to my saved trials
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Click here to add this to my saved trials
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Click here to add this to my saved trials
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Click here to add this to my saved trials
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
Click here to add this to my saved trials