Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Metastatic

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Combination of ganetespib and docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of NSCLC Stage IIIB or IV NSCLC ECOG Performance Status 0 or 1 Prior therapy defined as 1 prior systemic therapy for advanced disease measurable disease Radiologic evidence of disease progression following most recent prior treatment. Adequate hematologic, hepatic, renal function Exclusion Criteria: Active or untreated CNS metastases Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin Serious cardiac illness or medical conditions Pregnant or lactating women Uncontrolled intercurrent illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single agent docetaxel<br> | Drug: Docetaxel<br>* 75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion<br>|
| Experimental: Combination of ganetespib and docetaxel<br> | Drug: Combination of ganetespib and docetaxel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival in two co-primary populations |  | 14 months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced non-small cell lung cancer, NSCLC, Lung cancer