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
Open (Enrolling)
Both
Non Small Cell Lung Cancer

Thank you

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