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

NCT ID: NCT00496353

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-11-30

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.

Conditions

Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MK2461

MK2461 treatment, bid, 28-day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2007_016

Identifier Type: -

Identifier Source: secondary_id

2461-002

Identifier Type: -

Identifier Source: org_study_id