At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-04449913, AN ORAL HEDGEHOG INHIBITOR, IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW DOSE ARA-C OR DECITABINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME
In Brief
A Phase 2 clinical trial evaluating PF-04449913, Low dose ARA-C (LDAC), and 3 other interventions for Acute Myeloid Leukemia. Completed, enrolled 255 participants across 81 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
PF-04449913 administered orally and continuously for 28-days.
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
PF-04449913 administered orally and continuously for 28 days.
Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days
PF-04449913 administered orally and continuously for 28 days
Daunorubicin given using 60 mg/m2 for 3-days
Cytarabine 100 mg/m2 on days 1 through 7
PF-04449913 administered orally and continuously for 28 days
Daunorubicin given using 60 mg/m2 for 3-days
Cytarabine 100 mg/m2 on days 1 through 7
PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913)
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.