Clinical trial NCT01031225: A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Synta
STA 9090
ganetespib)
Lung Cancer
Non Small Cell Lung Cancer
NSCLC
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival rate
timeFrame: 16 weeks
Secondary outcomes:
measure: Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival
timeFrame: 18 months
measure: Safety and tolerability as measured by adverse event rates and laboratory evaluations
timeFrame: 16 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center; University of Arizona
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Santa Monica
country: United States
facility: UCLA Health System
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Atlanta
country: United States
facility: Emory University- Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina, Lineberger Comprehensive Cancer Center
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Hematology Oncology Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: