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Tracking Information | |
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First Received Date † | April 23, 2002 |
Last Updated Date | December 13, 2007 |
Start Date † | March 2002 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00034138 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients With Ovarian Epithelial Carcinoma |
Official Title † | |
Brief 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:
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Study Phase | Phase I, Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Condition † | Ovarian Neoplasms |
Intervention † | Drug: oregovomab |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Terminated |
Enrollment † | 24 |
Completion Date | December 2007 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female |
Ages | 18 Years to 65 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00034138 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Unither Pharmaceuticals |
Collaborators †† | |
Investigators † | |
Information Provided By | Unither Pharmaceuticals |
Verification Date | December 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |