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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 March 22, 2018
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FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham the Kirklin Clinic
Birmingham, Alabama, 35233 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
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 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.

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

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A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In 1st Line MDS, AML and CMML Patients
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myelodysplastic Syndrome
  • 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 of a 28 day cycle or on Days 1-5, 8-9 of a 28 day cycle
  • Drug: PF-04449913 (Glasdegib) Placebo
    Daily dose of the Placebo for PF-04449913 100 mg tablet in a continuous regimen of 28 day cycles.
  • Experimental: Arm A
    PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2
    Interventions:
    • Drug: PF-04449913 (Glasdegib)
    • Drug: Azacitidine
  • Active Comparator: Arm B
    PF-04449913 (Glasdegib) Placebo 100 mg + Azacitidine 75 mg/m2
    Interventions:
    • Drug: Azacitidine
    • Drug: PF-04449913 (Glasdegib) Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
November 6, 2021
November 7, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patient must meet all the following inclusion criteria to be eligible for enrollment into the study:

  1. Morphologically confirmed diagnosis of one of the following:

    1. MDS according to the WHO 2008 classification and bone marrow blasts > or = 5%
    2. AML with 20-30 % BM blasts and multi lineage dysplasia, according to WHO 2008 classification and WBC < 20x109/L
    3. CMML according to the WHO 2008 classification (Appendix 1) and BM blasts between 10% 19% and WBC < 13x109/L
  2. MDS patients must have Intermediate 2 (1.5 to 2.0 points) or High Risk (?2.5 points) disease according to the International Prognostic Scoring System 1997 (IPSS).
  3. MDS patients must have normal levels of vitamin B12 within the institutional range of normal as determined within 28 days of study entry.
  4. AML patients with 20- 30% BM blasts and multi lineage dysplasia, must have stable blast counts per Investigator's judgment.
  5. Clinical indication for treatment with azacitidine for MDS, AML or CMML.

Exclusion Criteria:

Patients with any of the following may not be included in the study:

  1. Patients with AML who are candidates for standard induction chemotherapy as first line treatment.
  2. Therapy related (secondary to radiation or chemotherapy) MDS or AML.
  3. Prior hypomethylating agents or cytotoxic chemotherapy for MDS, AML or CMML (prior immunosuppressive therapy and hydroxyurea are permitted provided that treatment is stopped within 8 and 2 weeks from study entry, respectively).
  4. Previous hematopoietic stem cell transplant.
  5. Prior treatment with a licensed or experimental smoothened inhibitor (SMOi) and/or hypomethylating agent (HMA).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Belgium,   Canada,   United Kingdom,   United States
Taiwan
 
NCT02367456
B1371012
2014-001345-24 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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