Phase 2
Completed N=27
A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
Source: ClinicalTrials.gov NCT01039519 ↗Enrolled (actual)
27
Serious AEs
37.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 — 18.5 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 |
18.5 | — |
| SECONDARY Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0 |
— | — |
| SECONDARY Kaplan-Meier Estimate of Progression Free Survival (PFS) |
1.8 | — |
| SECONDARY Kaplan-Meier Estimate of Overall Survival |
10.3 | — |
| SECONDARY Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET) |
66.7 | — |
| SECONDARY Count of Participants With Treatment-Emergent Adverse Events (AEs) |
27; 15; 10; 10; 1; 3 | — |
Eligibility Criteria
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) 470 msec
- Pregnant or lactating females
Data sourced from ClinicalTrials.gov (NCT01039519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.