An Open-label Phase 1b Study of PF-04449913 (Glasdegib) in Combination With Azacitidine in Patients With Previously Untreated Higher-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia
Description
Brief Summary
This multi center open label Phase 1b study is designed to evaluate the safety, efficacy,
pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined
with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome
(MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical
study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase
with an AML cohort and an MDS cohort.
Phase
N/AInclusion and Exclusion Criteria
- Patients must have previously untreated MDS, AML, or CMML according to the WHO 2016 classification.
- MDS patients must have Intermediate (>3 to 4.5 points), High Risk (>4.5
- 6) or Very High Risk (>6 points) disease according to the Revised International Prognostic Scoring System 2012 (IPSS-R).
- Clinical indication for treatment with azacitidine for MDS or AML.
- Patients with AML who are candidates for standard induction chemotherapy as first line treatment.
- Patients with known active CNS leukemia.
- Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.
Sites
Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.
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