Date: 2015-02-13
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Pfizer (USA - NY)
Product: glasdegib - PF-06463922
Action
mechanism: tyrosine kinase inhibitor/anaplastic lymphoma kinase (ALK) inhibitor
Disease: myelodysplastic syndrome, acute myeloid leukemia
Therapeutic area: Cancer - Oncology
Country: Belgium, Canada, Taiwan, UK, USA
Trial
details: 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 Risk Myelodysplastic 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. (NCT02367456)
Latest
news: * On February 13, 2015, a Phase 1-2 trial sponsored by Pfizer was published on the NIH website ClinicalTrials.gov for glasdegib and is currently recruiting participants.