A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies

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NCT02038777

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Study Location
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677, Japan
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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.
Acute Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies for monotherapy cohort.

- Patients with AML or High-Risk MDS who are newly diagnosed and previously untreated for combination cohort.

- Patients with AML who are newly diagnosed and previously untreated for azacitidine combination cohort.

- ECOG [Eastern Cooperative Oncology Group] performance status 0 to 2

- Adequate organ function

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


- Patients with active CNS disease


- Patient with active malignancy with the exception of basal cell carcinoma, non
melanoma skin cancer, carcinoma in situ cervical


- Patient has an active, life threatening or clinically significant uncontrolled
systemic infection

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
Official Title  ICMJE A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-04449913 (GLASDEGIB), AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS A SINGLE AGENT IN JAPANESE PATIENTS WITH SELECT HEMATOLOGIC MALIGNANCIES AND IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW-DOSE ARA-C, OR AZACITIDINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME
Brief Summary This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients. PF-04449913 will be administered orally as a single agent in patients with select advanced hematologic malignancies, or in combination with LDAC [Low-Dose Ara-C] or cytarabine and daunorubicin in previously untreated patients with AML [Acute Myeloid Leukemia] or high-risk MDS [Myelodysplastic Syndrome], or in combination with azacitidine in previously untreated patients with AML.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model Description:
MTD was determined in monotherapy cohort. Then two combination cohorts (Combination Cohorts 1 and 2) were added to evaluate the safety of glasdegib administered with chemotherapies. Another combination cohort (Combination Cohort 3) was added to evaluate the safety of glasdegib administered with Azacitidine. Then, Continuation Cohort which allows one Japanese patient enrolled from another trial in the same project was added. Afther that, Expansion Cohort of LDAC Combination for efficacy was added.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: PF-04449913
    PF-04449913 administered orally and continuously in 28 day cycles.
  • Drug: Low dose ARA-C (LDAC)
    Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
  • Drug: Daunorubicin
    Daunorubicin given using 60 mg/m2 for 3-days.
  • Drug: Cytarabine
    Cytarabine 100 mg/m2 on days 1 through 7.
  • Drug: Azacitidine
    Azacitidine Combination Cohort; Azacitidine 75 mg/m2 for 7 days.
  • Drug: LDAC
    Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
Study Arms  ICMJE
  • Experimental: Monotherapy Cohort
    PF-04449913 Monotherapy
    Intervention: Drug: PF-04449913
  • Experimental: Combination Cohort 1
    PF-04449913 in combination with low dose ARA-C (LDAC)
    Interventions:
    • Drug: PF-04449913
    • Drug: Low dose ARA-C (LDAC)
  • Experimental: Combination Cohort 2
    PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy.
    Interventions:
    • Drug: PF-04449913
    • Drug: Daunorubicin
    • Drug: Cytarabine
  • Experimental: Azacitidine Combination Cohort
    PF-04449913 in combination with azacitidine
    Interventions:
    • Drug: PF-04449913
    • Drug: Azacitidine
  • Experimental: Continuation Cohort
    PF-04449913 Monotherapy for one patient rolled-over from another trial in the same project.
    Intervention: Drug: PF-04449913
  • Experimental: Expansion Cohort of LDAC Combination for Efficacy
    PF-04449913 in combination with LDAC to evaluate efficacy
    Interventions:
    • Drug: PF-04449913
    • Drug: LDAC
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 8, 2020)		48
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2014)		24
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date November 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies for monotherapy cohort.
  • Patients with AML or High-Risk MDS who are newly diagnosed and previously untreated for combination cohort.
  • Patients with AML who are newly diagnosed and previously untreated for azacitidine combination cohort.
  • ECOG [Eastern Cooperative Oncology Group] performance status 0 to 2
  • Adequate organ function

Exclusion Criteria:

  • Patients with active CNS disease
  • Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical
  • Patient has an active, life threatening or clinically significant uncontrolled systemic infection
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02038777
Other Study ID Numbers  ICMJE B1371005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
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….
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 June 2020

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