A Study of MK0646 in Breast Cancer Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00759785

Purpose

A study to evaluate the response of growth factor signatures to a single dose of MK0646 in patients with stage I-IIIa breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: Comparator: MK0646	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Study to Establish Proof-of-Biology for MK0646 in Breast Cancer

Further study details as provided by Merck:

Primary Outcome Measures:

MK0646 will induce a decrease in the growth factor signature [ Time Frame: Following single dose of study drug infused over 60 - 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decrease in detectable expression of IGF1R in tumors [ Time Frame: Following single dose of study drug infused over 60 - 120 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0646	Drug: Comparator: MK0646 Single dose of MK0646 20 mg/kg infused over 60 - 120 minutes.

Eligibility

Criteria

Inclusion Criteria:

Patient has operable stage I-IIIa breast cancer of the following subtypes: (1) ER-negative, PR-negative, and HER2-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria- histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67> 10%
Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
Patient is female and > 18 years of age

Exclusion Criteria:

Patient is pregnant, breastfeeding or planning to become pregnant while in the study
Patient has received prior chemotherapy, biological therapy or radiation
Patient has participated in a clinical trial in the last 30 days
Patient has a history of drug or alcohol abuse in the last year
Patient is HIV positive
Patient has a history of Hepatitis B or C
Patient has poorly controlled diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759785

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Florida
Call for Information	Recruiting
Tampa, Florida, United States, 33612
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

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_554, MK0646-013
Study First Received:	September 24, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00759785
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009