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

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

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