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
Results First Received: February 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Intervention: Drug: Ganetespib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty-one patients were screened; 4 of the 31 were screen failures.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Treatment
    Ganetespib 200 mg/m^2  
STARTED     27  
COMPLETED     0 [1]
NOT COMPLETED     27  
Progressive disease                 20  
Treatment failure                 2  
Adverse Event                 3  
Physician Decision                 2  
[1] Reason not completed represents reason for terminating treatment.

Period 2:   Survival Follow-up
    Ganetespib 200 mg/m^2  
STARTED     27  
COMPLETED     0  
NOT COMPLETED     27  
Death                 23  
Sponsor decision                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set, which includes participants given at least one dose of study medication.

Reporting Groups
  Description
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.

Baseline Measures
    Ganetespib 200 mg/m^2  
Number of Participants  
[units: participants]
  27  
Age  
[units: years]
Mean (Standard Deviation)
  54.4  (8.35)  
Gender  
[units: participants]
 
Female     12  
Male     15  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     27  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     4  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     21  
More than one race     0  
Unknown or Not Reported     0  
Weight  
[units: kg]
Mean (Standard Deviation)
  74.94  (22.095)  
Height  
[units: cm]
Mean (Standard Deviation)
  171.57  (10.295)  
Body Surface Area (BSA)  
[units: m^2]
Mean (Standard Deviation)
  1.863  (0.2909)  
Time from Initial Gastrointestinal Stromal Tumor (GIST) Diagnosis to Consent [1]
[units: months]
Mean (Standard Deviation)
  68.71  (34.699)  
Time from Metastatic/Unresectable GIST Diagnosis to Consent [2]
[units: months]
Mean (Standard Deviation)
  46.77  (28.606)  
Eastern Cooperative Oncology Group (ECOG) Performance Status [3]
[units: participants]
 
0     14  
1     13  
Any Prior Exposure to Heat Shock Protein 90 (HSP90) Inhibitors  
[units: participants]
 
Yes     5  
No     21  
Unknown     1  
Prior Systemic Treatment for GIST  
[units: participants]
 
Yes     27  
No     0  
Number of Prior Systemic Treatment Regimens for GIST  
[units: regimens]
Mean (Standard Deviation)
  5.85  (2.476)  
Best Response From Prior Systemic Treatment [4]
[units: participants]
 
Complete response     3  
Partial response     6  
Stable Disease     17  
Progressive disease     1  
Unknown     0  
[1] N = 25 participants
[2] N = 20 participants GIST = gastrointestinal stromal tumor
[3]

The ECOG scale is as follows:

  • Grade 0: Fully active, able to carry on all pre-disease activities without restriction;
  • Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
  • Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;
  • Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours;
  • Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.
[4]

Target Lesion Response Criteria, RECIST (version 1.0)

  • Complete response - disappearance of all target lesions
  • Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions
  • Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease
  • Progressive disease - 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



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0   [ Time Frame: Week 16 up to Week 47 ]

3.  Secondary:   Kaplan-Meier Estimate of Progression Free Survival (PFS)   [ Time Frame: Day 1 up to Week 47 ]

4.  Secondary:   Kaplan-Meier Estimate of Overall Survival   [ Time Frame: Day 1 up to week 97 ]

5.  Secondary:   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 ]

6.  Secondary:   Count of Participants With Treatment-Emergent Adverse Events (AEs)   [ Time Frame: Day 1 up to Week 51 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: VP Clinical Research
Organization: Synta Pharmaceuticals
phone: 781-541-7156
e-mail: aoneill@syntapharma.com



Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01039519     History of Changes
Other Study ID Numbers: 9090-05
Study First Received: December 23, 2009
Results First Received: February 11, 2016
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration