Non Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGGanetespib
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).
Sponsors
Synta Pharmaceuticals Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed