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: February 11, 2016
Last verified: February 2016

December 23, 2009
February 11, 2016
January 2010
December 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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
Assessment of Clinical Benefit Rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01039519 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0 [ Time Frame: Week 16 up to Week 47 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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.

  • 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 ]
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.

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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
December 2011
December 2011   (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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01039519
9090-05
Yes
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
February 2016

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