drugset / Trial / NCT00034138

A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients With Ovarian Epithelial Carcinoma

NCT00034138

Phase 1/2 Terminated 24 enrolled Unither Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment with the cell culture product will be evaluated.

Timeline

Start
2002-03
Primary completion
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Oregovomab Monoclonal antibody 2 mg

Indications