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

a study on Myelodysplastic Syndrome Leukemia Acute Myeloid 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 MDS AML Syndrome Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia Azacitidine PF-04449913 (Glasdegib)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients must have previously untreated MDS or AML 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.
  • 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
  • Huntsman Cancer Hospital,University of Utah, accepting new patients
    Salt Lake City Utah 84112 United States
  • Huntsman Cancer Institute-University of Utah accepting new patients
    Salt Lake City Utah 84112 United States
  • Tom Baker Cancer Center-Alberta Health Services (AHS) - University Of Calgary accepting new patients
    Calgary Alberta T2N 4N2 Canada
  • Tom Baker Cancer Centre accepting new patients
    Calgary Alberta T2N 4N2 Canada
  • Kaye Edmonton Clinic accepting new patients
    Edmonton Alberta T6G 1Z1 Canada
  • University of Alberta Hospital accepting new patients
    Edmonton Alberta T6G 2B7 Canada
  • The Office of Lori Rackel accepting new patients
    Edmonton Alberta T6G 2V2 Canada

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 1
Study Type
Interventional
Last Updated
June 11, 2018