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The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single agent docetaxel | Active Comparator |
| |
| Combination of ganetespib and docetaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival in two co-primary populations | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | ORR is the proportion of subjects who achieve tumor response | 14 months |
| Determine qualitative and quantitative toxicities | AEs will be graded by NCI-CTC criteria. Tabulations of adverse events by frequency, relatedness and severity will be presented. Data will be presented by treatment arm and overall. No formal statistical analyses are planned. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synta Pharmaceuticals Investigative Site | Tucson | Arizona | 85715 | United States | ||
| Synta Pharmaceuticals Investigative Site |
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| Combination of ganetespib and docetaxel | Drug | Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle. |
|
| 14 months |
| Determine plasma drug concentrations of the combination | Assessed via measurement of Cmax levels. | 14 months |
| Evaluate Quality of Life | As measured by the EORTC QLQ -C30 questionnaire | 14 months |
| Disease Control Rate | Disease Control Rate is defined as the proportion of patients with best response, according to modified RECIST 1.1, of CR, PR or SD, where the SD must be for at least 6 weeks or 12 weeks. | 14 months |
| Tumor size change | Tumor size changes from baseline to at least 6 and 12 weeks | 14 months |
| Overall survival | 21 months |
| Santa Monica |
| California |
| 90404 |
| United States |
| Synta Pharmaceuticals Investigative Site | Atlanta | Georgia | 30322 | United States |
| Synta Pharmaceuticals Investigative Site | Chicago | Illinois | 60637 | United States |
| Synta Pharmaceutials Investigative Site | Boston | Massachusetts | 02215 | United States |
| Synta Pharmaceuticals Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Synta Pharmaceuticals Investigative Site | Kettering | Ohio | 45429 | United States |
| Synta Pharmaceuticals Investigative Site | Portland | Oregon | 97227 | United States |
| Synta Pharmaceuticals Investigative Site | Brussels | 1200 | Belgium |
| Synta Pharmaceuticals Investigative Site | Jette | 1090 | Belgium |
| Synta Pharmaceuticals Investigative Site | Yvoir | 5530 | Belgium |
| Synta Pharmaceuticals Investigative Site | Banja Luka | 78000 | Bosnia and Herzegovina |
| Synta Pharmaceuticals Investigative Site | Mostar | 88000 | Bosnia and Herzegovina |
| Synta Pharmaceuticals Investgative Site | Sarajevo | 71000 | Bosnia and Herzegovina |
| Synta Pharmaceuticals Investigative Site | Sarajevo | 71000 | Bosnia and Herzegovina |
| Synta Pharmaceuticals Investigative Site | Tuzla | 75000 | Bosnia and Herzegovina |
| Synta Pharmaceuticals Investigative Site | Hamilton | L8V 5C2 | Canada |
| Synta Pharmaceuticals Investigative Site | Montreal | H3A 1A1 | Canada |
| Synta Pharmaceuticals Investigative Site | Montreal | H3G 1A4 | Canada |
| Synta Pharmaceuticals Investigative Site | Ottawa | K1H 8L6 | Canada |
| Synta Pharmaceuticals Investigative Site | Pula | 52100 | Croatia |
| Synta Pharmaceuticals Investigative Site | Split | 21000 | Croatia |
| Synta Pharmaceuticals Investigative Site | Zagreb | 10000 | Croatia |
| Synta Pharmaceuticals Investigative Site | Prague | 180 00 | Czechia |
| Synta Pharmaceuticals Investigative Site | Halle | 06120 | Germany |
| Synta Pharmaceuticals Investigative Site | Hamburg | 22045 | Germany |
| Synta Pharmaceuticals Investigative Site | Mainz | 55131 | Germany |
| Synta Pharmaceuticals Investigative Site | Mannheim | 68167 | Germany |
| Synta Pharmaceuticals Investigative Site | Offenbach | 63069 | Germany |
| Synta Pharmaceuticals Investigative Site | Krakow | 31-115 | Poland |
| Synta Pharmaceuticals Investigative Site | Olsztyn | 10-357 | Poland |
| Synta Pharmaceuticals Investigative Site | Prabuty | 82-550 | Poland |
| Synta Pharmaceuticals Investigative Site | Szczecin | 70-891 | Poland |
| Synta Pharmaceuticals Investigative Site | Cluj-Napoca | 400015 | Romania |
| Synta Pharmaceuticals Investigative Site | Cluj-Napoca | 400058 | Romania |
| Synta Pharmaceuticals Investigative Site | Craiova | 200385 | Romania |
| Synta Pharmaceuticals Investigative Site | Suceava | 720237 | Romania |
| Synta Pharmaceuticals Investigative Site | Kazan' | 420029 | Russia |
| Synta Pharmaceuticals Investigative Site | Moscow | 105229 | Russia |
| Synta Pharmaceuticals Investigative Site | Moscow | 115478 | Russia |
| Synta Pharmaceuticals Investigative Site | Saint Petersburg | 194075 | Russia |
| Synta Pharmaceuticals Investigative Site | Saint Petersburg | 197758 | Russia |
| Synta Pharmaceuticals Investigative Site | Sochi | 354057 | Russia |
| Synta Pharmaceuticals Investigative Site | Voronezh | 394000 | Russia |
| Synta Pharmaceuticals Investigative Site | Belgrade | 11000 | Serbia |
| Synta Pharmaceuticals Investigative Site | Kamenitz | 21204 | Serbia |
| Synta Pharmaceuticals Investigative Site | Badalona | 08916 | Spain |
| Synta Pharmaceuticals Investigative Site | Barcelona | 08035 | Spain |
| Synta Pharmaceuticals Investigative Site | Madrid | 28040 | Spain |
| Synta Pharmaceuticals Investigational Site | Leicester | LE2 7HL | United Kingdom |
| Synta Pharmaceuticals Investigative Site | London | SE1 9RT | United Kingdom |
| Synta Pharmaceuticals Investigational Site | London | SW3 6JJ | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial 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 |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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