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Research and Clinical Trials

Brief Description  
To determine if paclitaxel plus AMG 386 is superior to paclitaxel plus placebo as measured by progression-free survival. Subjects will receive weekly paclitaxel + AMG 386/placebo weekly IV until unacceptable side effects or disease progression.
Who may be Eligible  

Key Inclusion criteria:

  • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Up to 3 prior chemotherapy regimens are allowed

Key Exclusion criteria:

  • Subjects with platinum-free interval (PFI) > 12 months from their last platinum-based therapy
  • History of central nervous system metastasis
  • Clinically significant cardiovascular disease within 12 months prior to randomization
  • Subjects with prinary platinum-refractory disease
IRB Number  
CHS1-10-431
Principal Investigator  
Hall, James

For More Information, Contact  Sarah  , Norek
Phone:  (704) 355-1520  Fax:  (704) 355-9897  
Email:  Sarah.Norek@carolinashealthcare.org
Address:Blumenthal Cancer Center 1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204
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