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