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

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NCT02367456

Last updated on January 21, 2020
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Study Location
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02367456
Pfizer
Active, not recruiting
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

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Pfizer Clinical Trials Contact Center

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Descriptive Information
Brief Title  ICMJE A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
Intervention  ICMJE
  • Drug: PF-04449913 (Glasdegib)
    Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles
  • Drug: Azacitidine
    75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle
Study Arms  ICMJE
  • Experimental: Arm A
    MDS patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2
    Interventions:
    • Drug: PF-04449913 (Glasdegib)
    • Drug: Azacitidine
  • Experimental: Arm B
    AML patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2
    Interventions:
    • Drug: PF-04449913 (Glasdegib)
    • Drug: Azacitidine
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 9, 2019) 		73
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2015) 		170
Estimated Study Completion Date  ICMJE January 28, 2021
Estimated Primary Completion Date January 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   United Kingdom,   United States
Removed Location Countries Taiwan
 
Administrative Information
NCT Number  ICMJE NCT02367456
Other Study ID Numbers  ICMJE B1371012
2014-001345-24 ( EudraCT Number )
BRIGHT MDS&AML1012 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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