Ovarian Cancer Clinical Trial
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Summary
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.
Eligibility Criteria
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)
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There are 2 Locations for this study
New York New York, 10065, United States
Nashville Tennessee, 37203, United States
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