A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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