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
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival rate
Outcome Time Frame:
16 weeks
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
9090-06
NCT ID:
NCT01031225
Start Date:
November 2009
Completion Date:
June 2013
Related Keywords:
- Non Small Cell Lung Cancer
- Synta
- STA 9090
- ganetespib)
- Lung Cancer
- Non Small Cell Lung Cancer
- NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| City of Hope Medical Center | Duarte, California 91010 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Genesis Cancer Center | Hot Springs, Arkansas 71913 |
| Swedish Medical Center | Seattle, Washington 98122-4307 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Ut Southwestern Medical Center | Dallas, Texas 75390 |
| Piedmont Hematology Oncology Associates | Winston Salem, North Carolina 27103 |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
| University of North Carolina, Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599 |
| Penn State Hershey Cancer Institute | Hershey, Pennsylvania 17033 |
| Arizona Cancer Center; University of Arizona | Tucson, Arizona 85724 |
| UCLA Health System | Santa Monica, California 90404 |
| Emory University- Winship Cancer Institute | Atlanta, Georgia 30322 |
