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Ridaforolimus+ Dalotuzumab · 3 trials · 2 indications
Progression free survival is defined as the time from randomization to progressive disease or death, which ever occurs earlier.
| Arm | Type | Description |
|---|---|---|
| Part A: ridaforolimus + dalotuzumab | EXPERIMENTAL | Approximately 15 patients will be enrolled to the ridaforolimus-dalotuzumab combination treatment arm. Subsequent Patients are randomly assigned in a 1:1 ratio to treatment with the ridaforolimus (20 mg daily five days a week)/dalotuzumab (intravenous infusion 10 mg/kg once weekly) combination therapy or cross-over to exemestane single-therapy treatment. |
| Part A: exemestane | ACTIVE_COMPARATOR | Exemestane 25 mg daily; single-agent therapy. |
| Part B: ridaforolimus + dalotuzumab | EXPERIMENTAL | Patients are randomly assigned in a 1:1 ratio to treatment with the ridaforolimus (20 mg daily five days a week)/dalotuzumab (intravenous infusion 10 mg/kg once weekly) combination therapy or cross-over to one of two single-therapy treatments (ridaforolimus alone or dalotuzumab alone). With the implementation of Amendment 3, this study arm will not be opened. |
| Part B: ridaforolimus | EXPERIMENTAL | Ridaforolimus; 40 mg daily five days a week, single-agent therapy. With the implementation of Amendment 3, this study arm will not be opened. |
| Part B: dalotuzumab | EXPERIMENTAL | Dalotuzumab intravenous infusion 10 mg/kg weekly; single-agent therapy. With the implementation of Amendment 3, this study arm will not be opened. |
| 1 | EXPERIMENTAL | 10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus |
| Ridaforolimus + Dalotuzumab | EXPERIMENTAL | Ridaforolimus (MK-8669) + Dalotuzumab (MK-0646) |
| Ridaforolimus | EXPERIMENTAL | Ridaforolimus (MK-8669) |
| Dalotuzumab | EXPERIMENTAL | Dalotuzumab (MK-0646) |
| Name | Type | Description |
|---|---|---|
| ridaforolimus + dalotuzumab | DRUG | Ridaforolimus 20 mg once daily (QD) five days a week, with the possibility of escalation to 30 mg once daily (QD) after the first cycle and dalotuzumab intravenous infusion 10 mg/kg once weekly (QW). Treatment will continue until disease progression. |
| exemestane | DRUG | Exemestane 25 mg daily (QD). Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval. |
| ridaforolimus | DRUG | Ridaforolimus 40 mg QD five days a week. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval. Note: the Sponsor-recommended dose of ridaforolimus when administered as a single agent is 40 mg/day, but when given in combination with dalotuzumab, it is given at 30 mg/day. |
| dalotuzumab | DRUG | Dalotuzumab intravenous infusion 10 mg/kg QW. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval. |
| trastuzumab | DRUG | single intravenous infusion every week; initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes |
Inclusion Criteria The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant: * Has a confirmed diagnosis of breast cancer that is metastatic or locally advanced and is estrogen receptor positive and human epidermal growth fa...
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Ridaforolimus + dalotuzumab is an investigational combination being studied in oncology. It has been evaluated in clinical trials for solid tumors, advanced or relapsed/refractory advanced cancer, breast neoplasms, prostate cancer, and in healthy volunteers. The combination is not approved and remains in clinical development.
Ridaforolimus + dalotuzumab is being developed by Merck & Company, Inc., traded on the New York Stock Exchange under the ticker MRK. The company has sponsored clinical trials evaluating this combination in various cancer settings.
Ridaforolimus + dalotuzumab has been studied in Phase 1 and Phase 2 clinical trials. The Phase 1 trials are completed, and a Phase 2 trial in breast cancer is also completed. The combination is investigational and not approved for any indication.
Ridaforolimus + dalotuzumab has been studied in completed trials including NCT00060632, NCT00112372, NCT00288431, and NCT01605396. These trials evaluated the combination in advanced malignancies, cancer, sarcoma, and breast cancer, with a total enrollment of 711 participants across all studies.
Ridaforolimus + dalotuzumab is a combination of two drugs, ridaforolimus and dalotuzumab. It is distinct from ridaforolimus alone. A Phase 2 trial compared ridaforolimus plus exemestane against ridaforolimus, dalotuzumab, and exemestane in breast cancer participants.