A Combination Study of PF-04449913 and Azacitidine In 1st Line MDS, AML and CMML Patients | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02367456

A Combination Study of PF-04449913 and Azacitidine In 1st Line MDS, AML and CMML Patients
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This multi center randomized (1:1), double blind, placebo controlled Phase 1b/2 study is designed to compare the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of PF 04449913 or placebo when combined with azacitidine in patients with previously untreated Intermediate 2 or High RiskMyelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) with 20-30% blasts and multi lineage dysplasia, and Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a Phase 1b safety lead in and (b) a randomized Phase 2.

Status: 
Recruiting
Study Date: 
Wed, 04/01/2015 to Fri, 06/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: PF-04449913 Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles Drug: Azacitidine 75mg/m2 on Days 1-7 of a 28 day cycle or on Days 1-5, 8-9 of a 28 day cycle Drug: PF-04449913 Placebo Daily dose of the Placebo for PF-04449913 100 mg tablet in a continuous regimen of 28 day cycles.