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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00563836
• Date of registration: 23/11/2007
• Prospective Registration: No
• Primary sponsor: Neovii Biotech
• Public title: Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
• Scientific 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
• Date of first enrolment: November 2007
• Target sample size: 41
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00563836
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria, Germany

Contacts

• Name: Jahlid Sehouli, MD
• Affiliation: Klinikum Charité, 13355 Berlin

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Epithelial Ovarian Cancer

Ovarian Cancer

Intervention(s)

Drug: Catumaxomab

Primary Outcome(s)

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(s)

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

Secondary ID(s)

IP-CAT-OC-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors