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Title:
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
Protocol Number:
J1229
Phase:
Phase I
Physician:
B Douglas Smith
Purpose:
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:
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.
Treatment:
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).
Population:
Adult
Last Update
09/19/2014 04:03 AM
 

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