MK2461 in Patients With Advanced Cancer (2461-001)(COMPLETED)

Phase 1

Completed

• Conditions: Advanced Cancer

• Registration Number: NCT00518739
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK2461.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-21
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients must be at least 18 years of age, with adequate organ function, and an ECOG performance of <2
• Patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during Part A)

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Exclusion Criteria

• No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
• Patients must not have primary central nervous system tumor
• Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of MK2461	18 Months

Secondary Outcome Measures

Name	Time	Method
To determine the Recommend Phase II Dose or doses (RP2D) based on safety, tumor pharmacodynamics, and parmacokinetics.	18 Months