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

Phase 1

Suspended

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer

• Registration Number: NCT00753480
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-16
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-06
• Last Update Posted: 2008-11-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 56

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence and nature of dose-limiting toxicities (DLTs)	Length of study

Secondary Outcome Measures

Name	Time	Method
Incidence, nature, and severity of adverse events	Length of study
Incidence of anti-D4064A antibodies	Length of study
Changes in vital signs and clinical laboratory results	Length of study

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Nashville, Tennessee, United States