Trial Information

Summary: An open-label dose escalation study of patients with solid tumors treated with STA-9090

This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 to evaluate for safety, tolerance and efficacy.

This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 during a 1-hour infusion 2 times per week (e.g., [Monday, Thursday] or [Tuesday, Friday]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 – 4). Further dose increments will be approximately 20% over the previous dose level, until the maximum tolerated dose (MTD) is determined.

Major Inclusion Criteria:

• Patients must be documented to be refractory or not candidates for current approved therapies.
• Must have anECOG status 0-2.
• Peripheral neuropathy =2.
• Must have acceptable organ and marrow function per protocol parameters.
• No clinically significant ventricular arrythmias or ischemia.

Major Exclusion Criteria:

• Must not be pregnant or breastfeeding.
• No chemotherapy or radiation within 3 weeks..
• No previous radiation to >25% of total bone marrow.
• No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation.
• No primary brain tumors or active brain metastases.
• No use of any investigational agents within 4 weeks.
• No treatment with chronic immunosuppressants.
• No uncontrolled, intercurrent illness.

Age Limits:

• =25 years of age

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Trial listings updated: September 4, 2008 at 3:18:43 PM