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

Paused · Phase 1

Conditions studied: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT00753480

Run by

Genentech, Inc.

People needed

56

Starts

2008-09-01

Last updated by the study team

2008-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Investigational Site — New York, New York, United States
• Investigational Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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