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Trial record 1 of 1 for:    NCT02038777
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A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT02038777
Recruitment Status : Recruiting
First Posted : January 17, 2014
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 14, 2014
First Posted Date  ICMJE January 17, 2014
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE March 25, 2014
Estimated Primary Completion Date August 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • First cycle Dose Limiting Toxicities [ Time Frame: 28 days after first dose ]
  • Disease Modifying Response Rate [ Time Frame: At the beginning of Cycle 9 (each cycle is 28 days). ]
    For the Expansion Cohort of LDAC Combination for efficacy only
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
First cycle Dose Limiting Toxicities [ Time Frame: 28 days after first dose ]
Change History Complete list of historical versions of study NCT02038777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 12 months ]
  • Time to reach maximum observed plasma concentration (Tmax) [ Time Frame: 12 months ]
  • Area under the plasma concentration curve (AUC) [ Time Frame: 12 months ]
  • Objective disease response [ Time Frame: 12 months ]
  • Disease-related gene mutation (PD biomarkers) [ Time Frame: 12 months ]
  • Detectable tumor Gli1 expression (PD Biomarkers) [ Time Frame: 12 months ]
  • Overall Survival (OS) [ Time Frame: 3 years ]
    For Azacitidine Combination Cohort and Expansion Cohort of LDAC Combination for Efficacy only
  • Probability of Participant Survival [ Time Frame: 1 years ]
    For Combination Cohort 1 only
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 12 months ]
  • Time to reach maximum observed plasma concentration (Tmax) [ Time Frame: 12 months ]
  • Area under the plasma concentration curve (AUC) [ Time Frame: 12 months ]
  • Objective disease response [ Time Frame: 12 months ]
  • Disease-related gene mutation (PD biomarkers) [ Time Frame: 12 months ]
  • Detectable tumor Gli1 expression (PD Biomarkers) [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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: Sequential Assignment
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2019)
49
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2014)
24
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date August 29, 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: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
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 March 2019

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