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)

NCT01220570 | Completed Phase 1

• 1 other identifier: 8669-050
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

breast cancer; ridaforolimus; ridaforolimus/dalotuzumab combination therapy

Outcome Measures

Primary Outcomes (1)

• The population mean change from baseline in GFS (Growth Factor Signature) score

  Baseline and Day 15

Secondary Outcomes (2)

• The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy

  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

  Baseline and Day 15

Study Arms (3)

Ridaforolimus + Dalotuzumab

EXPERIMENTAL

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

Drug: Ridaforolimus + Dalotuzumab

Ridaforolimus

EXPERIMENTAL

Ridaforolimus (MK-8669)

Drug: Ridaforolimus

Dalotuzumab

EXPERIMENTAL

Dalotuzumab (MK-0646)

Drug: Dalotuzumab

Interventions

Ridaforolimus + Dalotuzumab DRUG

Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks

Also known as: MK-8669, MK-0646

Ridaforolimus + Dalotuzumab

Ridaforolimus DRUG

Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets

Also known as: MK-8669

Ridaforolimus

Dalotuzumab DRUG

Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks

Also known as: MK-0646

Dalotuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ridaforolimus; dalotuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 21, 2015

Record last verified: 2015-01