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

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NCT02038777

Last updated on March 25, 2018
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FOR MORE INFORMATION
Study Location
Japanese Red Cross Nagoya First Hospital
Nagoya, Aichi, 453-8511 Japan
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.
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

NCT02038777
Pfizer
Recruiting
A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
A Phase 1 Study To Evaluate The Safety, Tolerability, 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
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.
Not Provided
Interventional
Phase 1
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. Now, under amendment 5, Continuation Cohort which allows one Japanese patient enrolled from another trial in the same project.

Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
October 31, 2019
October 31, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT02038777
B1371005
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
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

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1-800-718-1021

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