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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753480
Recruitment Status : Suspended
First Posted : September 16, 2008
Last Update Posted : November 7, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cancer Drug: D4064A Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Incidence, nature, and severity of adverse events [ Time Frame: Length of study ]
  2. Incidence of anti-D4064A antibodies [ Time Frame: Length of study ]
  3. Changes in vital signs and clinical laboratory results [ Time Frame: Length of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00753480

United States, New York
Investigational Site
New York, New York, United States, 10065
United States, Tennessee
Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech, Inc.
Study Director: Scott Holden, M.D. Genentech, Inc.

Responsible Party: Clinical Trials Posting Group, Genentech, Inc. Identifier: NCT00753480     History of Changes
Other Study ID Numbers: DMU4506g
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: November 7, 2008
Last Verified: November 2008

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female