Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
Phase 1
- Conditions
- Solid Tumors
- Interventions
- Drug: STA 9090 (ganetespib)
- Registration Number
- NCT00688116
- Lead Sponsor
- Synta Pharmaceuticals Corp.
- Brief Summary
An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)
- Detailed Description
This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ganetespib STA 9090 (ganetespib) -
- Primary Outcome Measures
Name Time Method The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug. Cycle 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
UCLA
🇺🇸Los Angeles, California, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC) - Cancer Center
🇺🇸Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States