Status:
TERMINATED
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Non-Small-Cell Lung Adenocarcinoma
Non-small Cell Lung Cancer Stage IIIB
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 patients with advanced non-small cell lung c...
Detailed Description
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activ...
Eligibility Criteria
Inclusion
- Advanced Stage IIIB or IV non-small-cell lung cancer (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
Exclusion
- Epidermal growth factor receptor (EGFR) mutations
- Anaplastic lymphoma kinase (ALK) translocations
- Predominantly squamous, adenosquamous or unclear histologic type
- Active or untreated central nervous system (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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT01798485
Start Date
April 1 2013
End Date
December 1 2015
Last Update
July 1 2016
Active Locations (267)
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1
Arizona Oncology Associates PC- NAHOA
Flagstaff, Arizona, United States, 86001
2
Arizona Oncology Associates, PC- NAHOA
Prescott Valley, Arizona, United States, 86314
3
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
4
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715