Title:
A Phase I Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 Administered Alone and in Combination with Chemotherapy in Subjects with Refractory or Recurrent Acute Myelogenous Leukemia (Protocol No. P07649 005))
Protocol Number:
J1195
Phase:
Phase I
Physician:
Ivana Gojo
Purpose:
The purpose of part 1 of this study is to establish the preliminary recommended Phase 2 dose for MK-8242 as monotherapy (Arm A) and in combination with cytarabine (Arm B) based on safety, tolerability, and pharmacokinetics in subjects with refractory or recurrent acute myelogenous leukemia. The purpose of part 2 of this study is to evaluate the complete remission and complete remission with incomplete marrow recovery rate of MK-8242 as monotherapy (Arm A) and in combination with cytarabine (Arm B) at the recommended phase 2 dose in subjects with refractory or recurrent wild type p53 AML.
Eligibility:
For Arm A, Part 1- the subject must have refractory or recurrent AML and be 18 or older. For Arm A, Part 1- the subject must have refractory or recurrent AML and be 18 or older with the p53 WT tumor status. For Arm B, Part 1-the subject must have recurrent AML and previously achieved a CR or Cri of 6-12 months duration following initial therapy and be between 18-70 years of age. For Arm B, Part 2-the subject must have recurrent AML and previously achieved a CR or Cri of 6-12 months duration from initial therapy and be between 18-70 with the p53 WT tumor status.
Treatment:
This is a multicentered trial. Patients will either be treated with MK-8242 as monotherapy (take MK-8242 on days 1-7 and 8-21 of a 28 day cycle) or combination therapy (take MK-8242 on days 1-7 and 8-21 of a 28 day cycle along with cytarabine q12 hours on days 1-4).
Population:
Adult
Last Update
05/23/2013 04:06 AM
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