Monocenter, double blinded, exploratory, randomized, study investigating the influence of Pasireotide on the hormonal activity of Pheochromocytoma – proof of concept study

Phase 1

• Conditions: Pheochromocytoma; MedDRA version: 9.1Level: LLTClassification code 10034876Term: Pheochromocytoma

• Registration Number: EUCTR2006-006824-20-DE
• Lead Sponsor: niversitätsklinikum Essen - Zentrum für Innere Medizin - Klinik für Endokrinologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-23
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Male and female patients.
• Age: 18-80 years
• Patients with malignant/ non-malignant Pheochromocytoma and/ or
Paraganglioma as shown by: - increased plasma values of metanephrines and
- confirmation by MRT/ CT not older than 3 months
• Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Clinically significant renal or hepatic abnormalities.
• Evidence of drug/alcohol abuse.
• The patient has received any unlicensed drug within 30 days prior to screening.
• Known hypersensitivity to somatostatin analogs
• Karnovsky-Index <60
• Pregnancy or breast-feeding
• Known immunosuppression
• Other malignant diseases, except Basalioma or in-situ Cervix carcinoma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified