A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
Purpose
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.
Conditions
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A |
MDS patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2 |
|
|
Experimental Arm B |
AML patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2 |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer