This trial is active, not recruiting.

Condition non small cell lung cancer
Treatment sta 9090
Phase phase 2
Sponsor Synta Pharmaceuticals Corp.
Start date November 2009
End date February 2014
Trial size 88 participants
Trial identifier NCT01031225, 9090-06


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
sta 9090
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

Primary Outcomes

Progression Free Survival rate
time frame: 16 weeks

Secondary Outcomes

Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival
time frame: 18 months
Safety and tolerability as measured by adverse event rates and laboratory evaluations
time frame: 16 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Non-Randomized, Open-label, Multi-Center, Multi-Cohort Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Synta Pharmaceuticals Corp..