A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
NCT02038777
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New York, New York
- Dresden,
- Frankfurt am Main,
- Heidelberg,
- Jena,
- Kiel,
- Leipzig,
- Mannheim,
- Münster,
- Nürnberg,
- Ann Arbor, Michigan
- Omaha, Nebraska
- Chicago, Illinois
- Indianapolis, Indiana
- Hershey, Pennsylvania
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 |
| ||||
Study Arms ICMJE |
| ||||
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 | 48 | ||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
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 |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
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 |