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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01220570
First received: October 12, 2010
Last updated: January 23, 2013
Last verified: January 2013
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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:
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 |
| ClinicalTrials.gov Identifier: | NCT01220570 History of Changes |
| Other Study ID Numbers: | 8669-050 |
| Study First Received: | October 12, 2010 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
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 May 16, 2013