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:
Synta Pharmaceuticals Corp.
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Gastrointestinal Stromal Tumor |
Intervention |
Drug: Ganetespib |
Enrollment | 27 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Thirty-one patients were screened; 4 of the 31 were screen failures. |
Arm/Group Title | 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. |
Period Title: Treatment | |
Started | 27 |
Completed | 0 [1] |
Not Completed | 27 |
Reason Not Completed | |
Progressive disease | 20 |
Treatment failure | 2 |
Adverse Event | 3 |
Physician Decision | 2 |
[1]
Reason not completed represents reason for terminating treatment.
|
|
Period Title: Survival Follow-up | |
Started | 27 |
Completed | 0 |
Not Completed | 27 |
Reason Not Completed | |
Death | 23 |
Sponsor decision | 4 |
Baseline Characteristics
Arm/Group Title | 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. | |
Overall Number of Baseline Participants | 27 | |
![]() |
Full analysis set, which includes participants given at least one dose of study medication.
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
Number Analyzed | 27 participants | |
54.4 (8.35) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 27 participants | |
Female |
12 44.4%
|
|
Male |
15 55.6%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 27 participants | |
Hispanic or Latino |
0 0.0%
|
|
Not Hispanic or Latino |
27 100.0%
|
|
Unknown or Not Reported |
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 27 participants | |
American Indian or Alaska Native |
0 0.0%
|
|
Asian |
4 14.8%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
|
Black or African American |
2 7.4%
|
|
White |
21 77.8%
|
|
More than one race |
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
|
Weight
Mean (Standard Deviation) Unit of measure: Kg |
||
Number Analyzed | 27 participants | |
74.94 (22.095) | ||
Height
Mean (Standard Deviation) Unit of measure: Cm |
||
Number Analyzed | 27 participants | |
171.57 (10.295) | ||
Body Surface Area (BSA)
Mean (Standard Deviation) Unit of measure: M^2 |
||
Number Analyzed | 27 participants | |
1.863 (0.2909) | ||
Time from Initial Gastrointestinal Stromal Tumor (GIST) Diagnosis to Consent
[1] Mean (Standard Deviation) Unit of measure: Months |
||
Number Analyzed | 27 participants | |
68.71 (34.699) | ||
[1]
Measure Description: N = 25 participants
|
||
Time from Metastatic/Unresectable GIST Diagnosis to Consent
[1] Mean (Standard Deviation) Unit of measure: Months |
||
Number Analyzed | 27 participants | |
46.77 (28.606) | ||
[1]
Measure Description: N = 20 participants GIST = gastrointestinal stromal tumor
|
||
Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 27 participants |
0 | 14 | |
1 | 13 | |
[1]
Measure Description:
The ECOG scale is as follows:
|
||
Any Prior Exposure to Heat Shock Protein 90 (HSP90) Inhibitors
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 27 participants |
Yes | 5 | |
No | 21 | |
Unknown | 1 | |
Prior Systemic Treatment for GIST
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 27 participants |
Yes | 27 | |
No | 0 | |
Number of Prior Systemic Treatment Regimens for GIST
Mean (Standard Deviation) Unit of measure: Regimens |
||
Number Analyzed | 27 participants | |
5.85 (2.476) | ||
Best Response From Prior Systemic Treatment
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 27 participants |
Complete response | 3 | |
Partial response | 6 | |
Stable Disease | 17 | |
Progressive disease | 1 | |
Unknown | 0 | |
[1]
Measure Description:
Target Lesion Response Criteria, RECIST (version 1.0)
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Sponsor has the right, 60 days before submission for publication, to review disclosures and require deletion of its confidential information, excluding the study results. Public disclosure shall be delayed for up to 60 additional days in order for the Sponsor to file a patent application, if needed. Single center publications will be postponed until after disclosure of pooled data (all sites), or, for a period of 18 months from study completion/termination at all participating sites.
Results Point of Contact
Name/Title: | VP Clinical Research |
Organization: | Synta Pharmaceuticals |
Phone: | 781-541-7156 |
EMail: | aoneill@syntapharma.com |
Responsible Party: | Synta Pharmaceuticals Corp. |
ClinicalTrials.gov Identifier: | NCT01039519 |
Other Study ID Numbers: |
9090-05 |
First Submitted: | December 23, 2009 |
First Posted: | December 25, 2009 |
Results First Submitted: | February 11, 2016 |
Results First Posted: | March 10, 2016 |
Last Update Posted: | March 10, 2016 |