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)

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220570
• Other study ID #: 8669-050
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2010
• Last updated: January 19, 2015
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• Ridaforolimus
Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets
• Dalotuzumab
Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The population mean change from baseline in GFS (Growth Factor Signature) score		Baseline and Day 15	No
Secondary	The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy		Baseline and Day 15	No
Secondary	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	No