A Combination Study With MK8669 and MK0646 in Patients With Advanced Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

August 6, 2008

Last Updated Date

November 24, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. [ Time Frame: MTD from Day 1 to Day 28 in Cycle 1 for disease progression ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. [ Time Frame: You will be evaluated for disease progression ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00730379 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with MK0646. [ Time Frame: At prescribed timepoints as defined in the protocol ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To measure pharmacokinetic and pharmacodynamic parameters with oral deforolimus as a single agent and in combination with MK0646. [ Time Frame: CT scan or MRI, done 14 days before dosing on Day 1 & 7 days before dosing in cycles 3, 5, 7 and every 2 cycles after (1 cycle is 28 days).Skin &/or tumor biopsies are required. FDG-PET scan may be required. ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

A Combination Study With MK8669 and MK0646 in Patients With Advanced Cancer

Official Title ^ICMJE

Phase I Combination Study of Deforolimus (Ridaforolimus/MK8669) and MK0646 in Patients With Advanced Cancer

Brief Summary

This study is being done to find the best tolerated dose of MK8669 and MK0646 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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Neoplasms

Intervention ^ICMJE

Drug: ridaforolimus + MK0646

Study Arms / Comparison Groups

Experimental: ridaforolimus (MK8669) + MK0646

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

United States, Spain

Administrative Information

NCT ID ^ICMJE

NCT00730379

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2008_538, MK8669-004

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Ariad Pharmaceuticals

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP