2N-13-2: A Randomized, Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma
Description
Detailed Description
This is an open-label, multicenter, randomized Phase 3 study of patients with Stage IIIB/IV NSCLC of adenocarcinoma histology.Primary Objective is to evaluate and compare overall survival (OS) in non-small cell lung cancer (NSCLC) patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone.Ganetespib is a novel synthetic small molecule that binds to the adenosine triphosphate (ATP) pocket in the N-terminus of Hsp90 and demonstrates significant activity for down-regulating Hsp90 client protein levels. This ability to impact a broad array of important oncogenes and cell signaling kinases is reflected in ganetespibs activity across a wide variety of tumor cell types.Patients will be randomized in a 1:1 ratio to receive either ganetespib in combination with docetaxel or docetaxel alone. The study will enroll approximately 500 patients, 12 from USC, over a planned 12-month period, and patients will be randomized into one of two treatment arms.
Phase
N/AInclusion and Exclusion Criteria
- Advanced Stage IIIB or IV NSCLC
- Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- Documented disease progression during or following most first line therapy for advanced disease
- Adequate hematologic, hepatic, renal function
- EGFR mutations
- ALK translocations
- Predominantly squamous, adenosquamous or unclear histologic type
- 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
Sites
Please contact Poornima Murali to learn more about where you can participate in this trial. Please use the contact form on the right side.
供电
SC CTSI