Status:
SUSPENDED
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00753480
Start Date
September 1 2008
Last Update
November 7 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site
New York, New York, United States, 10065
2
Investigational Site
Nashville, Tennessee, United States, 37203