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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01220570
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Breast Cancer Drug: Ridaforolimus + Dalotuzumab Drug: Ridaforolimus Drug: Dalotuzumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: 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 Name: MK-8669
Experimental: Dalotuzumab
Dalotuzumab (MK-0646)
Drug: Dalotuzumab
Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks
Other Name: MK-0646

Primary Outcome Measures :
  1. The population mean change from baseline in GFS (Growth Factor Signature) score [ Time Frame: Baseline and Day 15 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01220570     History of Changes
Other Study ID Numbers: 8669-050
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Merck Sharp & Dohme Corp.:
breast cancer
ridaforolimus/dalotuzumab combination therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antibodies, Monoclonal
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs