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

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: NCT01039519
Recruitment Status : Completed
First Posted : December 25, 2009
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

Tracking Information
First Submitted Date  ICMJE December 23, 2009
First Posted Date  ICMJE December 25, 2009
Results First Submitted Date  ICMJE February 11, 2016
Results First Posted Date  ICMJE March 10, 2016
Last Update Posted Date March 10, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 [ Time Frame: Week 16 up to Week 47 ]
Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.
  • CR: disappearance of all target lesions and non-target lesions and no new lesions
  • PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions
  • SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions
Original Primary Outcome Measures  ICMJE
 (submitted: December 24, 2009)
Assessment of Clinical Benefit Rate [ Time Frame: 15 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0 [ Time Frame: Week 16 up to Week 47 ]
    Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.
    • CR: disappearance of all target lesions and non-target lesions and no new lesions
    • PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions
  • Kaplan-Meier Estimate of Progression Free Survival (PFS) [ Time Frame: Day 1 up to Week 47 ]
    PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as
    • at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or
    • the appearance of 1 or more new lesions or
    • the unequivocal progression of existing nontarget lesions
  • Kaplan-Meier Estimate of Overall Survival [ Time Frame: Day 1 up to week 97 ]
    Overall survival was defined as the time from first dose to death or the date last known alive.
  • Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET) [ Time Frame: Day 2 to Day 10 ]
    PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999]. Tumor response was considered a complete response (CR) or a partial response (PR).
  • Count of Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: Day 1 up to Week 51 ]
    Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. Dose modification includes dose delay and dose reduction.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2009)
  • Assessment of the Objective Response Rate [ Time Frame: 16 months ]
  • Assessment of Progression-Free Survival [ Time Frame: 16 months ]
  • Assessment of Overall Survival [ Time Frame: 22 months ]
  • Assessment of safety and tolerability by adverse events rate 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 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

Planned:

  • Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
  • Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.

Analyzed:

  • Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumor
Intervention  ICMJE Drug: Ganetespib
Ganetespib 200 mg/m^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.
Other Name: STA-9090
Study Arms  ICMJE Experimental: ganetespib 200 mg/m^2
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Intervention: Drug: Ganetespib
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: January 30, 2014)
27
Original Estimated Enrollment  ICMJE
 (submitted: December 24, 2009)
55
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (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 computed tomography or magnetic resonance imaging as defined by Response Evaluation Criteria in Solid Tumors (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 central nervous system 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 corrected QT interval (QTc) > 470 msec
  • Pregnant or lactating females
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 NCT01039519
Other Study ID Numbers  ICMJE 9090-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Synta Pharmaceuticals Corp.
Original Responsible Party Robert Bradley, Synta Pharmaceuticals Corp.
Current Study Sponsor  ICMJE Synta Pharmaceuticals Corp.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Synta Pharmaceuticals Corp.
Verification Date February 2016

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