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NCT01546038 · ClinicalTrials.gov registry record · Phase 2
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 255
- Enrollment target
- 20
- Study locations
NCT01546038: Completed Phase 2 study of Acute Myeloid Leukemia, sponsored by Pfizer.
NCT01546038 is a Phase 2 study of Acute Myeloid Leukemia that has completed, run by Pfizer. The registered enrollment target is 255 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (122% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01546038, a Phase 2 study of Acute Myeloid Leukemia, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 255 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
Primary Outcome
A DLT was any of the following adverse events (AEs) in Cycle 1 and considered by the investigator possibly related to glasdegib in combination with chemotherapy: (1) Grade \>= 3 non-hematologic toxicity, excluding Grade \>= 3 infection, fever (including febrile neutropenia), infusion related AEs, electrolyte abnormalities and ALT/AST elevation that returned to Grade \<= 1 or baseline within 7 days; (2) prolonged myelosuppression that lasted longer than 42 days from the point of detection, define
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG PF-04449913
- DRUG Low dose ARA-C (LDAC)
Study Locations (20)
California
- UC San Diego Moores Cancer Center - Investigational Drug Services - La Jolla
- UC San Diego Medical Center - La Jolla - La Jolla
- UC San Diego Moores Cancer Center - La Jolla
- Keck Hospital of USC - Los Angeles
- LAC & USC Medical Center - Los Angeles
- USC/Norris Comprehensive Cancer Center / Investigational Drug Services - Los Angeles
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Ronald Reagan UCLA Medical Center Drug Information Center - Los Angeles
- Ronald Reagan UCLA Medical Center - Los Angeles
- UCLA Drug lnformation/lnvestigational Drugs - Los Angeles
- UCLA Hematology/Oncology Clinic - Los Angeles
- UC San Diego Medical Center - Hillcrest - San Diego
Alabama
- University of Alabama at Birmingham - Birmingham
- University of Alabama at Birmingham - Birmingham
- University of Alabama at Birmingham - Birmingham
Colorado
- University of Colorado Denver - Aurora
- University of Colorado Hospital - Aurora
Georgia
- Emory University Hospital - Atlanta
- Investigational Drug Service, Emory University Clinic - Atlanta
Florida
- H.Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2012-06-27 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 2 |
What the finished NCT01546038 record still lists
NCT01546038 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (122% higher).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Decitabine is the first listed.
NCT01546038 names 20 study sites across 5 states, led by California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT01546038 about?
NCT01546038 is a clinical study titled "A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome". This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
What is the current status of trial NCT01546038?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 255 participants. The study started on 2012-06-27. Estimated completion is 2019-03-04.
What conditions does trial NCT01546038 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT01546038?
The interventions under investigation include: Decitabine (DRUG), PF-04449913 (DRUG), Low dose ARA-C (LDAC) (DRUG).
Who is sponsoring clinical trial NCT01546038?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01546038 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01546038's enrollment target sits among peer trials
255 34th of 306 higher than 272 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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