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Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563836
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : October 3, 2012
Information provided by (Responsible Party):
Neovii Biotech

Brief Summary:
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Epithelial Ovarian Cancer Drug: Catumaxomab Phase 2

Detailed Description:

An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage design. The surgical procedure on Day 0 will be performed according to AGO State of the Art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. The Discharge Visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the End of Study Visit on Day 30.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Single-arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer
Study Start Date : November 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: 1 Drug: Catumaxomab
10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16

Primary Outcome Measures :
  1. the rate of all specific postoperative complications newly observed during a period of 30 days after surgery [ Time Frame: 30 days after surgery ]

Secondary Outcome Measures :
  1. safety and efficacy endpoints [ Time Frame: EOS is on day 30, post study period additional 23 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • signed and dated informed consent form before any protocol-specific screening procedures
  • patients has a primary diagnosis of an epithelial ovarian cancer including clear cell carcinoma (FIGO IA(G2-G3) - IV)
  • Karnofsky index > or equal 70
  • female at an age of 18 years or older
  • negative pregnancy test

Exclusion Criteria:

  • exposure to prior cancer therapy specific for ovarian cancer
  • previos treatment with non-humanized mouse or rat monoclonal antibodies
  • known / suspected hypersensitivity to catumaxomab or similar antibodies
  • second malignangcy within the last 5 years
  • presence of constant immunosuppressive therapy
  • presence of symptomatic heart failure or occlusive arterial diseases
  • inadequate renal or hepatic function
  • presence of any acute or chronic systemic infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563836

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Innsbruck, Austria
Klinikum Charité
Berlin, Germany, 13355
Sponsors and Collaborators
Neovii Biotech
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Principal Investigator: Jahlid Sehouli, MD Klinikum Charité, 13355 Berlin

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Responsible Party: Neovii Biotech Identifier: NCT00563836    
Other Study ID Numbers: IP-CAT-OC-02
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: August 2012
Keywords provided by Neovii Biotech:
ovarian cancer
phase II
trifunctional antibody
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Agents