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

Sponsor:	Merck
Collaborator:	Ariad Pharmaceuticals
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00730379

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: Comparator: ridaforolimus + dalotuzumab	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: AP 23573

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	87
Study Start Date:	July 2008
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 ridaforolimus (MK8669) + dalotuzumab (MK0646)	Drug: Comparator: ridaforolimus + dalotuzumab Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730379

Sponsors and Collaborators

Merck

Ariad Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00730379 History of Changes
Other Study ID Numbers:	2008_538, MK8669-004
Study First Received:	August 6, 2008
Last Updated:	December 17, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012