A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
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
1 other identifier
interventional
113
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2009
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedSeptember 19, 2014
September 1, 2014
3.7 years
November 16, 2009
September 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival rate
16 weeks
Secondary Outcomes (2)
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
Study Arms (1)
1
EXPERIMENTALInterventions
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Arizona Cancer Center; University of Arizona
Tucson, Arizona, 85724, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
City of Hope Medical Center
Duarte, California, 91010, United States
UCLA Health System
Santa Monica, California, 90404, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Emory University- Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of North Carolina, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2009
First Posted
December 14, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2013
Study Completion
February 1, 2014
Last Updated
September 19, 2014
Record last verified: 2014-09