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Sponsors and Collaborators: |
Fresenius Biotech GmbH Fresenius Biotech North America |
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Information provided by: | Fresenius Biotech GmbH |
ClinicalTrials.gov Identifier: | NCT00377429 |
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: catumaxomab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy |
Enrollment: | 43 |
Study Start Date: | September 2006 |
A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 4 months (includes the baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months follow-up), with post-study follow-up every 3 months for 2 years.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Inadequate hepatic function:
United States, Illinois | |
Gynecologic Oncology - Hinsdale | |
Hinsdale, Illinois, United States | |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States | |
United States, South Carolina | |
South Carolina Oncology AssociatesTelephone: 866-491-8137 | |
Columbia, South Carolina, United States |
Principal Investigator: | Michael V Seiden, MD, Ph.D | Massachusetts General Hospital |
Study ID Numbers: | IP-CAT-OC-01 |
Study First Received: | September 15, 2006 |
Last Updated: | October 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00377429 |
Health Authority: | United States: Food and Drug Administration |
Epithelial Cancer Epithelial Carcinoma Epithelial Ovarian Cancer Epithelial Ovarian Carcinoma Fallopian Tube Cancer Fallopian Tube Carcinoma Ovarian Cancer |
Ovarian Carcinoma Ovarian Epithelial Cancer Ovarian Epithelial Carcinoma Peritoneal Cancer Peritoneal Carcinoma Advanced Epithelial Ovarian Cancer |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Fallopian Tube Neoplasms Carcinoma Genital Diseases, Female Antibodies Endocrinopathy Fallopian tube cancer Immunoglobulins Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |