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| Sponsor: | Unither Pharmaceuticals |
|---|---|
| Information provided by: | Unither Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00034138 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Women's Cancer Research Foundation | |
| Miami, Florida, United States, 33143 | |
| Walt Disney Memorial Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00034138 History of Changes |
| Other Study ID Numbers: | OVA-Gy-16 |
| Study First Received: | April 23, 2002 |
| Last Updated: | December 13, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
immunotherapy monoclonal antibody Stage III ovarian epithelial cancer Stage IV ovarian epithelial cancer |
|
Neoplasms Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |