A Study of Dalotuzumab (MK0646) in Breast Cancer Patients (0646-013)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00759785
First received: September 24, 2008
Last updated: May 15, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00759785     History of Changes
Other Study ID Numbers: 0646-013, MK0646-013, 2008_554
Study First Received: September 24, 2008
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014