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

A Non-randomized, Open Label, Multi-center Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Patients With Metastatic and/or Unresectable GIST Resistant or Refractory to Prior Systemic Treatments Including Imatinib and Sunitinib

The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.

Planned:

• Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
• Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.

Analyzed:

• Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.

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