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)

Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Actual Enrollment :
63 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Clinical Trial to Qualify the Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ridaforolimus + Dalotuzumab

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

Drug: Ridaforolimus + Dalotuzumab
Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks
Other Names:
  • MK-8669, MK-0646
  • Experimental: Ridaforolimus

    Ridaforolimus (MK-8669)

    Drug: Ridaforolimus
    Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets
    Other Names:
  • MK-8669
  • Experimental: Dalotuzumab

    Dalotuzumab (MK-0646)

    Drug: Dalotuzumab
    Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks
    Other Names:
  • MK-0646
  • Outcome Measures

    Primary Outcome Measures

    1. The population mean change from baseline in GFS (Growth Factor Signature) score [Baseline and Day 15]

    Secondary Outcome Measures

    1. The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy [Baseline and Day 15]

    2. 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]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC Identifier:
    Other Study ID Numbers:
    • 8669-050
    First Posted:
    Oct 14, 2010
    Last Update Posted:
    Jan 21, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Merck Sharp & Dohme LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 21, 2015