MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00496353
• Collaborator: (none)
• Enrollment: 26
• Duration (Months): 17.1

Study Details

Study Description

Brief Summary

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 Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Outcome Measures

Primary Outcome Measures

1. To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated. [18 Months]

Secondary Outcome Measures

1. 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. [18 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must be at least 18 years of age, with adequate organ function, and an ecog performance of <2

Exclusion Criteria:

• No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation

• Patients must not have primary central nervous system tumor

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00496353
• Other Study ID Numbers: 2461-002; 2007_016
• First Posted: Jul 4, 2007
• Last Update Posted: Mar 31, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Merck Sharp & Dohme LLC: Neoplasm Malignant
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Mar 31, 2015