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A Study of Dalotuzumab (MK0646) in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00759785
First received: September 24, 2008
Last updated: March 1, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: Comparator: Dalotuzumab (MK0646)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Establish Proof-of-Biology for MK0646 in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Dalotuzumab 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 ]

Enrollment: 48
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dalotuzumab
 Drug: Comparator: Dalotuzumab (MK0646)
Single dose of Dalotuzumab 20 mg/kg infused over 60 - 120 minutes.
Other Name: MK0646

  Eligibility

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00759785     History of Changes
Other Study ID Numbers: 2008_554, MK0646-013
Study First Received: September 24, 2008
Last Updated: March 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013