A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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
1 other identifier
interventional
56
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 12, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedNovember 7, 2008
November 1, 2008
September 12, 2008
November 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and nature of dose-limiting toxicities (DLTs)
Length of study
Secondary Outcomes (3)
Incidence, nature, and severity of adverse events
Length of study
Incidence of anti-D4064A antibodies
Length of study
Changes in vital signs and clinical laboratory results
Length of study
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (2)
Investigational Site
New York, New York, 10065, United States
Investigational Site
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott Holden, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2008
First Posted
September 16, 2008
Study Start
September 1, 2008
Last Updated
November 7, 2008
Record last verified: 2008-11