Overview

This trial is active, not recruiting.

Condition breast neoplasms
Treatments ridaforolimus, dalotuzumab, exemestane
Phase phase 2
Target IGFR
Sponsor Merck Sharp & Dohme Corp.
Start date July 2012
End date February 2014
Trial size 84 participants
Trial identifier NCT01605396, 8669-064

Summary

The purpose of the study is to evaluate the progression free survival (PFS) of ridaforolimus, dalotuzumab and exemestane (R/D/E) compared to the combination of ridaforolimus and exemestane (R/E) in post-menopausal participants with breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ridaforolimus MK-8669
Participants receiving 10 mg PO (orally) QD (daily) of ridaforolimus in the triplet and 30 mg in the doublet may escalate to 20 mg QDx5 and 40 mg QDx5 respectively in the absence of grade 2 or above stomatitis in the initial cycle of treatment.
dalotuzumab MK-0646
10 mg/kg/week intravenously. Note: Based upon evaluation of additional data the sponsor may adjust the starting dose of dalotuzumab, which may be changed to 7.5 mg/kg/week.
exemestane Aromasin
25 mg PO QD
(Active Comparator)
ridaforolimus MK-8669
Participants receiving 10 mg PO (orally) QD (daily) of ridaforolimus in the triplet and 30 mg in the doublet may escalate to 20 mg QDx5 and 40 mg QDx5 respectively in the absence of grade 2 or above stomatitis in the initial cycle of treatment.
exemestane Aromasin
25 mg PO QD

Primary Outcomes

Measure
Progression-free Survival (PFS)
time frame: Baseline until disease progression, assessed throughout entire study duration (up to approximately 27 months)

Secondary Outcomes

Measure
Percent Reduction in Sum of Target Lesion Sizes
time frame: Baseline to Week 16
Objective response rate (ORR)
time frame: Baseline until participant no longer responds to treatment, assessed throughout entire study duration (up to approximately 27 months)
Overall survival (OS)
time frame: Baseline until death, assessed throughout entire study duration (up to approximately 27 months)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and Human Epidermal Growth Factor Receptor 2 (HER-2) negative, and Ki67 (a tumor marker) ≥ 15% determined by the central study laboratory - Post-menopausal - With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole - Has at least one confirmed measurable metastatic lesion - Has a performance status ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale - Has a life expectancy of at least 3 months - Adequate organ function Exclusion Criteria: - Is receiving any other concurrent systemic tumor therapy, including hormonal agents and HER-2 inhibitors - Previously received rapamycin or rapamycin analogs, including ridaforolimus, temsirolimus, or everolimus - Received prior treatment with Insulin-like Growth Factor 1 Receptor (IGF-1R) inhibitors, Phosphatidylinositol 3-Kinase (PI3K) inhibitors, or other experimental agents that target PI3K, Protein Kinase B (AKT), or Mammalian Target of Rapamycin (mTOR) pathway - Is receiving chronic corticosteroids administered at doses greater than those used for normal replacement therapy - Has active brain metastasis or leptomeningeal carcinomatosis; patients with adequately treated brain metastases are eligible if they meet certain criteria - Known allergy to macrolide antibiotics - Has an active infection requiring antibiotics - Significant or uncontrolled cardiovascular disease - Poorly controlled Type 1 or 2 diabetes - Is known to be Human Immunodeficiency Virus (HIV) positive - Has a known history of active hepatitis B or C. Healthy carriers of hepatitis B are not allowed on this study

Additional Information

Official title A Phase II Randomized Trial of the Combination of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in High Proliferation, Estrogen Receptor Positive Breast Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..