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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_599 |
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| Name | Class |
|---|---|
| Ariad Pharmaceuticals | INDUSTRY |
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This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.
Allocation and Arms Additional Information: All Patients will receive an 8-week
open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)
Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridaforolimus | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lead-In Ridaforolimus | Drug | Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) in the randomized population | Randomization (Week 8) and every 8 weeks until progressive disease or death |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) in the full analysis population | Study entry (Visit 1) and every 8 weeks until progressive disease or death | |
| Overall survival (OS) in the full analysis population | From study entry (Visit 1) to death due to any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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|
| Comparator: Blinded Ridaforolimus | Drug | Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday |
|
|
| Comparator: Blinded Placebo | Drug | Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday |
|
| OS in the randomized population | From study entry (Visit 1) to death due to any cause |
| PFS in the full analysis population | Study entry (Visit 1) and every 8 weeks until progressive disease or death |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C515074 | ridaforolimus |
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