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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |