NCT00034138

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Unither Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, open-label, randomized, parallel group, Phase 1/2 study in female patients with Stage III/IV epithelial ovarian cancer. The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. The study will also evaluate the safety of the cell culture product and the immune responses in patients following treatment. The study is being conducted in three phases: 1. The pharmacokinetic assessment phase will include at least 24 patients, who will be randomized into two treatment groups to receive a single 2 mg dose of either ascites fluid product or cell culture product. 2. The treatment phase will continue administration of two more monthly doses (weeks 4 and 8) and all patients will receive cell culture product. Study patients will be followed for safety and immune response through week 20. 3. The continuation phase will continue administration of cell culture product at the discretion of the investigator on a quarterly schedule for up to 104 weeks in eligible patients who tolerate therapy. Patients who continue treatment will be followed for serious adverse events and all patients will be followed for survival for up to 2 years after first treatment.

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	oregovomab

Timeline

• Start date: 2002-03-01
• Completion: 2007-12-01
• First posted: 2002-04-24
• Last updated: 2007-12-18

Locations

8 sites across 1 country: United States