Ovarian Cancer Clinical Trial
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
Verified date | November 2008 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 56 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Investigational Site | Nashville | Tennessee |
United States | Investigational Site | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and nature of dose-limiting toxicities (DLTs) | Length of study | ||
Secondary | Incidence, nature, and severity of adverse events | Length of study | ||
Secondary | Incidence of anti-D4064A antibodies | Length of study | ||
Secondary | Changes in vital signs and clinical laboratory results | Length of study |
Status | Clinical Trial | Phase | |
---|---|---|---|
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