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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Intervention / Treatment
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* Drug: D4064A


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: D4064A|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of dose-limiting toxicities (DLTs) |  | Length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EOC, PPC, FTC