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Trial record 1 of 1 for:    NCT01031225
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A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01031225
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

Tracking Information
First Submitted Date  ICMJE November 16, 2009
First Posted Date  ICMJE December 14, 2009
Last Update Posted Date September 19, 2014
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
Progression Free Survival rate [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival [ Time Frame: 18 months ]
  • Safety and tolerability as measured by adverse event rates and laboratory evaluations [ Time Frame: 16 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
  • Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival [ Time Frame: 18 months ]
  • Safety and tolerability based on adverse event rates and laboratory evaluations [ Time Frame: 16 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE Drug: STA 9090
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval
Study Arms  ICMJE Experimental: 1
Intervention: Drug: STA 9090
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2014)
113
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2009)
42
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01031225
Other Study ID Numbers  ICMJE 9090-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Synta Pharmaceuticals Corp.
Study Sponsor  ICMJE Synta Pharmaceuticals Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Synta Pharmaceuticals Corp.
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP