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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00753480
First received: September 12, 2008
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Drug: D4064A
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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

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

Estimated Enrollment: 56
Study Start Date: September 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753480

Locations
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.
Investigators
Study Director: Scott Holden, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00753480     History of Changes
Other Study ID Numbers: DMU4506g
Study First Received: September 12, 2008
Last Updated: November 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
EOC
PPC
FTC

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014