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
B Douglas Smith
Johns Hopkins Kimmel Cancer Center in Baltimore
This is a Phase 1b study to define safety and preliminary effectiveness of PF-04449913 (a hedgehog inhibitor) in combination with intensive chemotherapy(cytarabine and daunorubicin), low-dose cytarabine or decitabine in previously untreated patients with AML or high-risk MDS.
Eligibility for the â??unfitâ?? and â??fitâ?? arms are defined by specific patient characteristics which have been shown to predict mortality rates during intense chemotherapy administration.
The study consists of three parallel arms with PF-04449913 (hedgehog inhibitor) administered in combination with 1ow-dose cytarabine (Arm A) or decitabine (Arm B) in patients who are â??unfitâ?? to tolerate intensive chemotherapy, or PF-04449913 administered in combination with cytarabine and daunorubicin in patients â??fitâ?? to tolerate more intensive chemotherapy(Arm C).
07/27/2015 09:39 AM