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

NCT ID: NCT00759785

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-02-17

Brief Summary

A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ER-positive Luminal B

Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.

Group Type: EXPERIMENTAL

dalotuzumab (MK0646)

Intervention Type: DRUG

Single intravenous infusion

Triple Negative

Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.

Group Type: EXPERIMENTAL

dalotuzumab (MK0646)

Intervention Type: DRUG

Single intravenous infusion

Interventions

dalotuzumab (MK0646)

Single intravenous infusion

Intervention Type: DRUG

Other Intervention Names

MK-0646

Eligibility Criteria

Inclusion Criteria

• Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (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 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
• Participant is female and ≥18 years of age

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-0646-013

Identifier Type: OTHER

Identifier Source: secondary_id

2008-004180-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0646-013

Identifier Type: -

Identifier Source: org_study_id