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

October 2, 2012 updated by: Neovii Biotech

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
  • Germany
      • Berlin, Germany, 13355
        • Klinikum Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of all specific postoperative complications newly observed during a period of 30 days after surgery
Time Frame: 30 days after surgery
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and efficacy endpoints
Time Frame: EOS is on day 30, post study period additional 23 months
EOS is on day 30, post study period additional 23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovii Biotech

Investigators

  • Principal Investigator: Jahlid Sehouli, MD, Klinikum Charité, 13355 Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 23, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-CAT-OC-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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