Back to resultsA Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
STA 9090
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Synta, STA 9090, ganetespib), Lung Cancer, 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
Sites / Locations
- Arizona Cancer Center; University of Arizona
- Genesis Cancer Center
- City of Hope Medical Center
- UCLA Health System
- University of Colorado Cancer Center
- Emory University- Winship Cancer Institute
- Rush University Medical Center
- University of Chicago Medical Center
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Massachusetts General Hospital
- Dana Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Nevada Cancer Institute
- Hackensack University Medical Center
- University of North Carolina, Lineberger Comprehensive Cancer Center
- Piedmont Hematology Oncology Associates
- Oregon Health and Science University
- Penn State Hershey Cancer Institute
- Vanderbilt-Ingram Cancer Center
- UT Southwestern Medical Center
- Swedish Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival rate
Secondary Outcome Measures
Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival
Safety and tolerability as measured by adverse event rates and laboratory evaluations
Full Information
NCT ID
NCT01031225
First Posted
November 16, 2009
Last Updated
September 18, 2014
Sponsor
Synta Pharmaceuticals Corp.
1. Study Identification
Unique Protocol Identification Number
NCT01031225
Brief Title
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
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Synta, STA 9090, ganetespib), Lung Cancer, Non Small Cell Lung Cancer, NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STA 9090
Intervention Description
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
Primary Outcome Measure Information:
Title
Progression Free Survival rate
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival
Time Frame
18 months
Title
Safety and tolerability as measured by adverse event rates and laboratory evaluations
Time Frame
16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona Cancer Center; University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA Health System
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University- Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of North Carolina, Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Piedmont Hematology Oncology Associates
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
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