A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)

Phase 1

Completed

• Conditions: Neoplasms

• Registration Number: NCT00730379
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.

Detailed Description

Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist
• In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens
• You must be over the age of 18 years old
• You must have a ECOG status performance of 0 or 1
• You must have good organ function
• You must be willing to have skin and/or tumor biopsies

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Exclusion Criteria

• You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies
• You have an active infection that requires treatment
• You are HIV positive or have a history of Hepatitis B or C

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.	MTD from Day 1 to Day 28 in Cycle 1 for disease progression

Secondary Outcome Measures

Name	Time	Method
To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab	At prescribed timepoints as defined in the protocol