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Sponsored by: |
Unither Pharmaceuticals |
Information provided by: | Unither Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00034138 |
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.
Condition | Intervention | Phase |
Ovarian Neoplasms |
Drug: oregovomab |
Phase I Phase II |
MedlinePlus related topics: | Cancer Ovarian Cancer |
Drug Information available for: | Oregovomab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Estimated Enrollment: | 24 |
Study Start Date: | March 2002 |
Study Completion Date: | December 2007 |
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:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
Walt Disney Memorial Cancer Institute | |||||
Orlando, Florida, United States, 32804 | |||||
Women's Cancer Research Foundation | |||||
Miami, Florida, United States, 33143 | |||||
United States, Indiana | |||||
St. Joseph's Medical Center | |||||
South Bend, Indiana, United States, 46634 | |||||
United States, Iowa | |||||
University of Iowa Hospitals and Clinics | |||||
Iowa City, Iowa, United States, 52242 | |||||
United States, Pennsylvania | |||||
Magee-Women's Hospital | |||||
Pittsburgh, Pennsylvania, United States, 15213 | |||||
United States, Tennessee | |||||
Baptist Hospital of East Tennessee | |||||
Knoxville, Tennessee, United States, 37920 | |||||
United States, Texas | |||||
MD Anderson Cancer Center | |||||
Houston, Texas, United States, 77030 | |||||
United States, West Virginia | |||||
Mary Babb Randolph Cancer Center | |||||
Morgantown, West Virginia, United States, 26506 |
Unither Pharmaceuticals |
Study ID Numbers: | OVA-Gy-16 |
First Received: | April 23, 2002 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00034138 |
Health Authority: | United States: Food and Drug Administration |
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