A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC)
- Registration Number
- NCT01562015
- Lead Sponsor
- Synta Pharmaceuticals Corp.
- Brief Summary
Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers. Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Males or females aged 18 years or older
- Pathological confirmation of advanced NSCLC
- Evidence of a translocation or an inversion event involving the ALK gene locus
- ECOG Performance Status 0 or 1
Exclusion Criteria
- Prior therapy with ALK-targeted agents
- Prior treatment with Hsp90 inhibitor
- Known EGFR activating mutation
- Presence of active or untreated central nervous system (CNS) metastases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ganetespib Ganetespib Ganetespib IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
- Primary Outcome Measures
Name Time Method Objective response rate 1 year
- Secondary Outcome Measures
Name Time Method Duration of Response 1 year Disease Control Rate 6 weeks and 12 weeks Adverse events 1 year Progression Free Survival From the date of study drug start until the date of first documented progression or date of death from any cause, whichever comes frist, assessed up to 3 years Overall Survival 1 year
Trial Locations
- Locations (1)
Synta Pharmaceuticals Investigative Site
🇨🇦Toronto, Ontario, Canada