At a glance
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A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating MK-5108 and docetaxel for Cancer, Neoplasms, Tumors. Completed, enrolled 35 participants.
Detailed Summary
This study will investigate the safety, side effects and how well the body tolerates MK-5108 as well as determine different doses of MK-5108 in participants with advanced and/or refractory solid tumors. The corresponding primary hypotheses of this study are that 1) administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum of side effects observed in these participants after administration of oral MK-5108 alone and in combination with docetaxel will be dose-dependent and allow for definition of a maximum tolerated dose (MTD).
Study Details
Timeline
Interventions
MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.
Docetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m\^2 Q12H during the first 2 days of each 21-day cycle.