Brief Title
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of D4064A Administered Intravenously to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer After a Platinum-Containing Regimen
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence and nature of dose-limiting toxicities (DLTs)
Secondary Outcome
Incidence, nature, and severity of adverse events
Condition
Fallopian Tube Cancer
Intervention
D4064A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
56
Start Date
September 2008
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Scott Holden, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00753480
Organization ID
DMU4506g
Study Sponsor
Genentech, Inc.
Study Sponsor
Scott Holden, M.D., Study Director, Genentech, Inc.
Verification Date
November 2008