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))
This is a study of MK-8242 alone and in combination with cytarabine in adult participants
with refractory or recurrent acute myelogenous leukemia (AML). The study will have 2 Arms.
Arm A is for participants with refractory or recurrent AML who are considered ineligible for
standard chemotherapy. In Part 1 of Arm A, participants will receive MK-8242 monotherapy in
escalating doses to determine the recommended phase 2 dose [RP2D]. In Part 2, participants
will receive monotherapy with MK-8242 to confirm the RP2D and assess preliminary efficacy.
Arm B is for participants with recurrent AML following an initial complete remission (CR) or
CR with incomplete marrow recovery (CRi) of 6 to 12 months duration. In Part 1 of Arm B,
participants will receive MK-8242 + cytarabine in escalating doses to determine the RP2D in
combination with cytarabine. In Part 2, participants will receive MK-8242 + cytarabine to
confirm the RP2D and assess preliminary efficacy. The pharmacokinetics of MK-8242 will be
studied in both arms. With Amendment 4 (22 August 2013) a 21-day dosing cycle is added, with
MK-8242 being given on Days 1-7 of each 21-day cycle in both the monotherapy and combination
therapy arms; data from Arm A will be used to determine whether a participant receives
21-day or 28-day therapy in Arm B.
View this trial on ClinicalTrials.gov
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