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Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers. Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganetespib | Experimental | Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganetespib | Drug | Ganetespib 200 mg/m2 administered 1 time per week for the first three weeks of a four week treatment cycle (Days 1, 8, and 15 of the 28 Day treatment cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | 1 year | |
| Disease Control Rate | 6 weeks and 12 weeks | |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synta Pharmaceuticals Investigative Site | Tampa | Florida | 33612 | United States | ||
| Synta Pharmaceuticals Investigative Site |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C533237 | STA 9090 |
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| 1 year |
| Progression Free Survival | From the date of study drug start until the date of first documented progression or date of death from any cause, whichever comes frist, assessed up to 3 years |
| Overall Survival | 1 year |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Synta Pharmaceuticals Investigative Site | Hamilton | Ontario | ON L8V 5C2 | Canada |
| Synta Pharmaceuticals Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Synta Pharmaceuticals Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |