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

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NCT02367456

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Study Location
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
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Contact
1-800-718-1021
[email protected]
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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.

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Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic LeukemiaA Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
NCT02367456
  1. Cleveland, Ohio
  2. Salt Lake City, Utah
  3. Salt Lake City, Utah
  4. Calgary, Alberta
  5. Edmonton, Alberta
  6. Lille cedex,
  7. Lille cedex,
  8. Lille Cedex,
  9. Birmingham, Alabama
  10. Birmingham, Alabama
  11. Birmingham, Alabama
  12. La Jolla, California
  13. La Jolla, California
  14. New Haven, Connecticut
  15. New Haven, Connecticut
  16. New Haven, Connecticut
  17. Baltimore, Maryland
  18. Lebanon, New Hampshire
  19. Bronx, New York
  20. Bronx, New York
  21. Buffalo, New York
  22. Stony Brook, New York
  23. Stony Brook, New York
  24. Durham, North Carolina
  25. Durham, North Carolina
  26. Cleveland, Ohio
  27. Nashville, Tennessee
  28. Nashville, Tennessee
  29. Seattle, Washington
  30. Seattle, Washington
  31. Jette, Brussels
  32. Antwerpen,
  33. Leuven,
  34. Edmonton, Alberta
  35. Edmonton, Alberta
  36. Amiens cedex 01,
  37. Amiens,
  38. Angers,
  39. Angers,
  40. Paris Cedex 10,
  41. Paris Cedex 10,
  42. Paris Cedex 10,
  43. Pierre Benite Cedex,
  44. Pierre-Benite Cedex,
  45. Pierre-Benite,
  46. Tours Cedex 01,
  47. Berlin,
  48. Braunschweig,
  49. Liverpool,
  50. London,
  51. Newcastle upon Tyne,
  52. Oxford,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 31, 2021
Actual 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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP