Back to resultsA Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Primary Purpose
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
D4064A
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring EOC, PPC, FTC
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)
Sites / Locations
- Investigational Site
- Investigational Site
Outcomes
Primary Outcome Measures
Incidence and nature of dose-limiting toxicities (DLTs)
Secondary Outcome Measures
Incidence, nature, and severity of adverse events
Incidence of anti-D4064A antibodies
Changes in vital signs and clinical laboratory results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00753480
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Suspended
Study Start Date
September 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Keywords
EOC, PPC, FTC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
D4064A
Primary Outcome Measure Information:
Title
Incidence and nature of dose-limiting toxicities (DLTs)
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
Incidence, nature, and severity of adverse events
Time Frame
Length of study
Title
Incidence of anti-D4064A antibodies
Time Frame
Length of study
Title
Changes in vital signs and clinical laboratory results
Time Frame
Length of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Holden, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
We'll reach out to this number within 24 hrs