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A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01039519
First received: December 23, 2009
Last updated: September 17, 2014
Last verified: September 2014

December 23, 2009
September 17, 2014
December 2009
June 2012   (final data collection date for primary outcome measure)
Assessment of Clinical Benefit Rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01039519 on ClinicalTrials.gov Archive Site
  • Assessment of the Objective Response Rate [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Assessment of Progression-Free Survival [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Assessment of Overall Survival [ Time Frame: 22 months ] [ Designated as safety issue: No ]
  • Assessment of safety and tolerability by adverse events rate and laboratory evaluations [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
A Non-randomized, Open Label, Multi-center Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Patients With Metastatic and/or Unresectable GIST Resistant or Refractory to Prior Systemic Treatments Including Imatinib and Sunitinib

The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
Drug: STA-9090 (ganetespib)
STA-9090 (ganetespib) IV infusion once weekly for 3 consecutive weeks followed by one week dose free interval until disease progression
Experimental: STA-9090 (ganetespib)
Intervention: Drug: STA-9090 (ganetespib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be at least 18 years of age at the time of study entry
  • Must have histologically confirmed metastatic and/or unresectable GIST
  • Must have measurable disease on CT or MRI as defined by RECIST
  • Must have documented failure (due to either progression or intolerance)of at least prior imatinib and sunitinib. Previous administration of other known heat shock protein 90 (Hsp90) inhibitors is permitted
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Must have acceptable laboratory values as defined in the protocol

Exclusion Criteria:

  • Known CNS metastases
  • Major surgery within 4 weeks prior to receiving STA-9090
  • Use of any investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter prior to receiving STA-9090
  • No treatment with chronic immunosuppressants
  • Must have otherwise adequate health status as defined in the protocol
  • Left ventricular ejection fraction (LVEF) < than or = 50% at baseline
  • Baseline QTc > 470 msec
  • Pregnant or lactating females
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01039519
9090-05
No
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
September 2014

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