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)

January 19, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The population mean change from baseline in GFS (Growth Factor Signature) score
Time Frame: Baseline and Day 15
Baseline and Day 15

Secondary Outcome Measures

Outcome Measure
Time Frame
The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy
Time Frame: Baseline and Day 15
Baseline and Day 15
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
Baseline and Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (ESTIMATE)

October 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8669-050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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