Pharmacokinetics of bevacizumab in patients with malignant ascites

Completed

• Conditions: 10027476; ascites

• Registration Number: NL-OMON32123
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Malignant ascites
2. At least 18 years of age
3. WHO performance status 0-2
4. Adequate haematological, hepatic, and renal function
5. Signed written informed consent
6. Able to comply with the protocol

Exclusion Criteria

1. Patients receiving chemotherapy
2. Radiotherapy within 14 days before the start of the study of the involved area
3. Major surgery within 28 days before the initiation of the study
4. Clinically significant cardiovascular disease
5. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause
6. CNS metastases (CT-scan not mandatory)
7. Treatment with any investigational drug within 30 days before the start of the study
8. Prior allergic reaction to immunoglobulins or immunoglobulin allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The pharmacokinetic of intravenously and intraperitoneally administered<br /><br>111In-bevacizumab will be assesed in serum and ascites.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-VEGF levels in ascites and serum will be assesed.<br /><br>-The efficacy of bevacizumab in malignant ascites will be assesed.</p><br>