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

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: deforolimus + MK0646	Phase I

MedlinePlus related topics:

Cancer

Drug Information available for:

Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	Phase I Combination Study of MK8669 (Deforolimus) and MK0646 (IGF-1R) Monoclonal Antibody in Patients With Advanced Cancer

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: You will be evaluated for disease progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

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

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
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 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

Contacts


Contact: Toll Free Number	1-888-577-8839

Locations


United States, Tennessee
	Call for Information	Recruiting
	Nashville, Tennessee, United States, 37203

Spain
	Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
	Madrid, Spain, 28027
	Contact: Jorge Gonzalez-Esteban 34-91-3210-728

Sponsors and Collaborators

Merck

Ariad Pharmaceuticals

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_538, MK8669-004
First Received:	August 6, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00730379
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal

Antibodies

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	Merck Ariad Pharmaceuticals
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00730379