Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PHASE2 | COMPLETED | 115 | — | — | Sep 17, 2010 | Oct 15, 2013 | May 31, 2017 | - | — |
| NCT00736970 | Oral Deforolimus With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer (8669-009) | PHASE2 | COMPLETED | 34 | — | — | Jul 1, 2008 | May 1, 2011 | Aug 27, 2015 | - | — |
| NCT01220570 | 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) | PHASE1 | COMPLETED | 63 | — | — | Sep 1, 2010 | Dec 1, 2012 | Jan 21, 2015 | - | — |
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...