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)

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Ridaforolimus + Dalotuzumab; Drug: Ridaforolimus; Drug: Dalotuzumab

• Registration Number: NCT01220570
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridaforolimus + Dalotuzumab	Ridaforolimus + Dalotuzumab	Ridaforolimus (MK-8669) + Dalotuzumab (MK-0646)
Ridaforolimus	Ridaforolimus	Ridaforolimus (MK-8669)
Dalotuzumab	Dalotuzumab	Dalotuzumab (MK-0646)

Primary Outcome Measures

Name	Time	Method
The population mean change from baseline in GFS (Growth Factor Signature) score	Baseline and Day 15

Secondary Outcome Measures

Name	Time	Method
The correlation between change in Ki67 expression and change in GFS after two weeks of treatment with ridaforolimus/dalotuzumab (MK-8669/MK-0646) combination therapy, ridaforolimus (MK-8669) monotherapy and/or dalotuzumab (MK-0646) monotherapy	Baseline and Day 15
The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy	Baseline and Day 15