Overview

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

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Synta Pharmaceuticals Corp.
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) < than or = 50% at baseline

- Baseline corrected QT interval (QTc) > 470 msec

- Pregnant or lactating females