Ovarian Neoplasms Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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