A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

a study on Myelodysplastic Syndrome Acute Myeloid Leukemia Leukemia

Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Keywords

Myelodysplastic Syndrome Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia MDS AML CMML Syndrome Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Azacitidine PF-04449913 (Glasdegib)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of California San Diego (UCSD) accepting new patients
    La Jolla California 92093 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02367456
Phase
Phase 2
Study Type
Interventional
Last Updated