A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of D4064A Administered Intravenously to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer After a Platinum-Containing Regimen

This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A administered by IV infusion to patients with recurrent or persistent epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have previously received a platinum-containing regimen. The study will enroll up to 56 patients at up to six investigative sites in the United States.

Inclusion Criteria:

• ECOG performance status of 0 or 1
• Advanced, histologically documented epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 12 months of treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists
• History of receiving five or fewer prior chemotherapy-containing regimens for EOC, PPC, or FTC (including primary therapy)

Exclusion Criteria:

• Prior treatment with chemotherapy or experimental anti-cancer agents within 4 weeks prior to Day 1
• Prior treatment with oregovomab (OvaRex(R)) or abagovomab
• History or clinical evidence of central nervous system or brain metastases
• Grade ≥ 2 peripheral neuropathy
• History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
• History of clinically symptomatic liver disease, including viral or other hepatitis, history of or current alcoholism, or cirrhosis
• Untreated or persistent/recurrent malignancy (other than EOC, PPC, or FTC)