At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating PF-04449913, Low dose ARA-C (LDAC), and 4 other interventions for Acute Myeloid Leukemia. Completed, enrolled 48 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
PF-04449913 administered orally and continuously in 28 day cycles.
PF-04449913 administered orally and continuously in 28 day cycles.
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
PF-04449913 administered orally and continuously in 28 day cycles.
Daunorubicin given using 60 mg/m2 for 3-days.
Cytarabine 100 mg/m2 on days 1 through 7.
PF-04449913 administered orally and continuously in 28 day cycles.
Azacitidine Combination Cohort; Azacitidine 75 mg/m2 for 7 days.
PF-04449913 administered orally and continuously in 28 day cycles.
Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.