Solid Tumors
Conditions
Keywords
metastatic cancer, solid tumor, histologically or cytologically confirmed non-hematological, malignancy that is metastatic or unresectable for which no, standard therapy exists, STA-9090, ganetespib
Brief summary
An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)
Interventions
This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients must be documented to be refractory or not candidates for current approved therapies. * Must have an ECOG status 0-2. * Peripheral neuropathy \< or = 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. * Chemotherapy or radiation within 3 weeks. * Previous radiation to \>25% of total bone marrow. * Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation. * Primary brain tumors or active brain metastases. * Use of any investigational agents within 4 weeks. * Treatment with chronic immunosuppressants. * Uncontrolled, intercurrent illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities | Cycle 1 |
Countries
United States