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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by Synta Pharmaceuticals Corp..
Recruitment status was Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Synta Pharmaceuticals Corp.

ClinicalTrials.gov Identifier:

NCT01039519

First received: December 23, 2009

Last updated: March 19, 2012

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 23, 2009
Last Updated Date	March 19, 2012
Start Date ^ICMJE	December 2009
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 24, 2009)	Assessment of Clinical Benefit Rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01039519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 24, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
Official Title ^ICMJE	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
Brief Summary	The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Gastrointestinal Stromal Tumor
Intervention ^ICMJE	Drug: STA-9090 (ganetespib) STA-9090 (ganetespib) IV infusion once weekly for 3 consecutive weeks followed by one week dose free interval
Study Arm (s)	Not Provided
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	Active, not recruiting
Estimated Enrollment ^ICMJE	55
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01039519
Other Study ID Numbers ^ICMJE	9090-05
Has Data Monitoring Committee	No
Responsible Party	Synta Pharmaceuticals Corp.
Study Sponsor ^ICMJE	Synta Pharmaceuticals Corp.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Synta Pharmaceuticals Corp.
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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