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
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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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...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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