MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)
This study has been completed.
Information provided by (Responsible Party):
First received: August 17, 2007
Last updated: April 26, 2013
Last verified: April 2013
This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of MK2461 in Patients With Advanced Cancer|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- To evaluate the safety and tolerability of MK2461 [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Patients will be administered oral MK2461 twice daily and will be treated for 28 day cycles. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of MK2461. 60 mg dry filled capsules, escalating to 240 mg ( for dosing in Cohort 4 & beyond).
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