An open label, multicenter, pilot phase II study of SOM230 s.c. in patients with duodeno-pancreatic (neuro) endocrine tumors and different pituitary diseases (Nelson?s syndrome, non-functioning adenoma, TSH-adenoma, Gonadotroph adenoma, and PRL-adenoma) with potential sensitivity to somatostatin analogues. - ND

Conditions: duodeno-pancreatic (neuro) endocrine tumors and different pituitary diseases (Nelson?s syndrome, non-functioning adenoma, TSH-adenoma,Gonadotroph adenoma, and PRL-adenoma)
MedDRA version: 6.1Level: HLTClassification code 10035098

Registration Number: EUCTR2006-002877-30-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Male or female patients >= 18 years ? Patients with pituitary disease or duodeno-pancreatic (neuro) endocrine tumors diagnosed with the criteria described in Table 5-1 ? Karnofsky status >60 ? Patients must have had the following washout periods: octreotide LAR - 8 weeks, octreotide s.c. - 48 hours, lanreotide (Autogel) - 8 weeks, lanreotide SR - 4 weeks. ? Written informed consent obtained prior to any screening procedures ? Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for 30 days after the study has ended. Male patients are required to use a condom throughout the study and for at least 30 days following study completion. Specific inclusion criteria by tumor type, refer to Table 5-1: ? Insulinoma ? 72 hour fast: glycopenic symptoms, low glycemia (3.3 mmol/l and inappropriately high level of insulinemia) ? Gastrinoma ? Symptoms not controlled by Proton Pump Inhibitor (PPI) and/or tumor progression. PPI could be continued throughout the study. ? PRL-adenoma ? Macroadenoma (adenoma > 10mm) not controlled by dopamine agonist. Dopamine agonist could be continued throughout study. ? Non-functioning pituitary adenoma, Gonadotroph adenoma, PRL-adenoma and Nelson?s syndrome ? Prior radiotherapy received must be at least 12 months before start of study
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

Patients with active gall bladder disease ? Poorly controlled diabetes mellitus as indicated by the presence of HbA1c > 9% (Not applicable for glucagonoma patients). ? Patients with additional active malignant diseases within the last five years (with the exception of correctly treated basal cell carcinoma or carcinoma in situ of the cervix) ? Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor?s Medical Monitor ? Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Patients who have participated in any clinical investigation with an investigational drug within 30 days prior to dosing ? Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study