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| Sponsored by: |
Unither Pharmaceuticals |
| Information provided by: | Unither Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00050375 |
Purpose
This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.
| Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: oregovomab |
Phase III |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| Drug Information available for: | Oregovomab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Intravenous OvaRex® MAb-B43.13 as Post Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian, Tubal or Peritoneal Origin |
| Estimated Enrollment: | 354 |
| Study Start Date: | December 2002 |
| Study Completion Date: | December 2007 |
This a Phase III, double-blind, placebo-controlled, multi-center study of intravenous OvaRex® MAb-B43.13 as post-chemotherapy consolidation for epithelial carcinoma of ovarian, tubal, or peritoneal origin.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 62 Study Locations |
| Unither Pharmaceuticals |
More Information
| Study ID Numbers: | OVA-Gy-17 |
| First Received: | December 5, 2002 |
| Last Updated: | December 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00050375 |
| Health Authority: | United States: Food and Drug Administration |
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