The Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer (MK-8669-050)

NCT ID: NCT01220570

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-12-31

Brief Summary

This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score among participants with breast cancer.

Conditions

Breast Cancer

Study Design

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

Study Groups

Ridaforolimus + Dalotuzumab

Ridaforolimus (MK-8669) + Dalotuzumab (MK-0646)

Group Type: EXPERIMENTAL

Ridaforolimus + Dalotuzumab

Intervention Type: DRUG

Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks

Ridaforolimus

Ridaforolimus (MK-8669)

Group Type: EXPERIMENTAL

Ridaforolimus

Intervention Type: DRUG

Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets

Dalotuzumab

Dalotuzumab (MK-0646)

Group Type: EXPERIMENTAL

Dalotuzumab

Intervention Type: DRUG

Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks

Interventions

Ridaforolimus + Dalotuzumab

Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks

Intervention Type: DRUG

Ridaforolimus

Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets

Intervention Type: DRUG

Dalotuzumab

Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks

Intervention Type: DRUG

Other Intervention Names

MK-8669, MK-0646; MK-8669; MK-0646

Eligibility Criteria

Inclusion Criteria

• Participant has operable Stage I-IIIa invasive breast cancer of the following subtype: ER-positive, HER2-negative tumor with histologic grade 2 or 3 and Ki67 ≥ 15%
• Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
• Participant consents to provide an existing tissue sample or to have a core needle biopsy before drug administration
• Participant consents to provide tissue samples following drug administration by a second core needle biopsy or from a surgical specimen
• Participant must have adequate organ function

Exclusion Criteria

• Participant has received any prior chemotherapy, biological therapy or radiotherapy for breast cancer
• Participant has a known hypersensitivity to the components of study drugs or their analogs, including hypersensitivity to macrolide antibiotics (e.g. clarithromycin, erythromycin, azithromycin).
• Participant has poorly controlled diabetes mellitus, or requires insulin for glucose control.
• Participant is unable to swallow capsules and/or absorb oral medications
• Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
• Participant is known to be Human Immunodeficiency Virus (HIV)-positive
• Participant has known history of active Hepatitis B or C.
• Participant is concurrently using growth hormone (GH) or growth hormone inhibitors
• Participant has significant or uncontrolled cardiovascular disease, including heart failure, unstable angina, or a myocardial infarction within the last 6 months

• 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

Other Identifiers

8669-050

Identifier Type: -

Identifier Source: org_study_id