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

Genentech

Status and phase

Suspended

Phase 1

Conditions

Peritoneal Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: D4064A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00753480

DMU4506g

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)