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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Ganetespib 200 mg/m2 administered 1 time per week for the first three weeks of a four week treatment cycle (Days 1, 8, and 15 of the 28 Day treatment cycle).
Synta Pharmaceuticals Investigative Site
Tampa, Florida, United States
Synta Pharmaceuticals Investigative Site
Cleveland, Ohio, United States
Synta Pharmaceuticals Investigative Site
Hamilton, Ontario, Canada
Synta Pharmaceuticals Investigative Site
Ottawa, Ontario, Canada
Objective response rate
Time frame: 1 year
Duration of Response
Time frame: 1 year
Disease Control Rate
Time frame: 6 weeks and 12 weeks
Adverse events
Time frame: 1 year
Progression Free Survival
Time frame: 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
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Synta Pharmaceuticals Investigative Site
Toronto, Ontario, Canada