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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01220570
First received: October 12, 2010
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The population mean change from baseline in GFS (Growth Factor Signature) score [ Time Frame: Baseline and Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy [ Time Frame: Baseline and Day 15 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01220570     History of Changes
Other Study ID Numbers: 8669-050
Study First Received: October 12, 2010
Last Updated: December 26, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 20, 2014