A Phase I Study of MK-4827 for Treatment of Solid Tumors (MK-4827-005)
This study has been terminated.
Information provided by:
First received: October 21, 2010
Last updated: June 26, 2012
Last verified: June 2012
This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.
|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 Study of MK-4827 in Patients With Solid Tumor|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Incidence of dose-limiting toxicities (DLTs) in Cycle 1 [ Time Frame: Cycle 1 of treatment (1 cycle = 21 days) ] [ Designated as safety issue: Yes ]Dose-limiting toxicities are defined as all adverse experiences that are clearly not related to disease progression or intercurrent illness. In order to be declared a dose-limiting toxicity, an adverse experience must be related (definitely, probably, or possibly) to study therapy.
|Study Start Date:||November 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: MK-4827 once daily
MK-4287, 150 mg or 300 mg capsule, orally, once daily in 21 day cycles.
Contacts and Locations
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