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

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ClinicalTrials.gov Identifier: NCT00563836
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech

Tracking Information
First Submitted Date  ICMJE November 23, 2007
First Posted Date  ICMJE November 26, 2007
Last Update Posted Date October 3, 2012
Study Start Date  ICMJE November 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2007)
the rate of all specific postoperative complications newly observed during a period of 30 days after surgery [ Time Frame: 30 days after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00563836 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2007)
safety and efficacy endpoints [ Time Frame: EOS is on day 30, post study period additional 23 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
Official Title  ICMJE 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
Brief Summary Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Epithelial Ovarian Cancer
Intervention  ICMJE Drug: Catumaxomab
10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Catumaxomab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 23, 2007)
41
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00563836
Other Study ID Numbers  ICMJE IP-CAT-OC-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neovii Biotech
Study Sponsor  ICMJE Neovii Biotech
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jahlid Sehouli, MD Klinikum Charité, 13355 Berlin
PRS Account Neovii Biotech
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP