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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00753480
• Other study ID #: DMU4506g
• Status: Suspended
• Phase: Phase 1
• First received: September 12, 2008
• Last updated: November 6, 2008
• Start date: September 2008

Study information

• Verified date: November 2008
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 56
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cancer

Intervention

Drug:
• D4064A

Locations

Country	Name	City	State
United States	Investigational Site	Nashville	Tennessee
United States	Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities (DLTs)		Length of study
Secondary	Incidence, nature, and severity of adverse events		Length of study
Secondary	Incidence of anti-D4064A antibodies		Length of study
Secondary	Changes in vital signs and clinical laboratory results		Length of study