drugset / Trial / NCT01234857

A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)

NCT01234857

Phase 2 Completed 115 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a two-part study that will determine, if: 1) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to exemestane; and 2) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to both ridaforolimus and dalotuzumab as single agents, in participants with breast cancer.

Timeline

Start
2010-09-17
Primary completion
2013-10-15
Completion
2013-10-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Exemestane Small molecule 25 mg Oral
Subject dalotuzumab Monoclonal antibody 10 mg/kg Intravenous
Subject ridaforolimus Small molecule 10 mg Oral
Subject ridaforolimus Small molecule 20 mg Oral
Subject ridaforolimus Small molecule 30 mg Oral
Subject ridaforolimus Small molecule 40 mg Oral

Indications