NCT00753480SuspendedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Suspended
- Sponsor
- Genentech, Inc.
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Incidence and nature of dose-limiting toxicities (DLTs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
Incidence and nature of dose-limiting toxicities (DLTs)
Time Frame: Length of study
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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