MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00496353|
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : March 31, 2015
The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461.
The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm||Drug: MK2461||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||November 2008|
- To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated. [ Time Frame: 18 Months ]
- To evaluate the anti-tumor efficacy of MK2461 in patients with advanced solid tumor by assessing the response rate, progression- free survival, duration of response, time to response and time to progression. [ Time Frame: 18 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496353
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|