Non Small Cell Lung Cancer
Conditions
Keywords
Synta, STA 9090, ganetespib), Lung Cancer, Non Small Cell Lung Cancer, NSCLC
Brief summary
This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).
Interventions
DRUGSTA 9090
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
Sponsors
Synta Pharmaceuticals Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression * Availability of tissue for analysis * ECOG Performance Status 0 or 1 * Adequate organ function as defined in the protocol. * Must be at least 18 years old and able and willing to sign a written informed consent document
Exclusion criteria
* Poor venous access requiring an indwelling catheter for study drug administration * Women who are pregnant or lactating * Ventricular ejection fraction \< or = to 55% at baseline * Any uncontrolled intercurrent illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival rate | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival | 18 months |
| Safety and tolerability as measured by adverse event rates and laboratory evaluations | 16 months |
Countries
United States
Outcome results
None listed