duodeno-pancreatic (neuro) endocrine tumors and different pituitary diseases (Nelson?s syndrome, non-functioning adenoma, TSH-adenoma,Gonadotroph adenoma, and PRL-adenoma) MedDRA version: 6.1 Level: HLT Classification code 10035098
Conditions
Interventions
Product Code: SOM230
Pharmaceutical Form: Solution for injection
Current Sponsor code: SOM230
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .9-
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of SOM230 s.c. in patients with rare life threatening diseases as follows: Biochemical tumor markers for those patients with duodeno-pancreatic (neuro) endocrine tumors (insulinoma, glucagonoma and VIPoma) and Thyrotropin-pituitary adenoma (TSH-adenoma) ? Tumor response for those patient with pituitary diseases (Nelson?s syndrome, nonfunctioning pituitary adenoma, Gonadotroph adenoma, and Prolactin-pituitary adenoma (PRL-adenoma) and gastrinoma.;Secondary Objective: To assess the overall safety of SOM230 s.c. in this diverse population ? To assess the effect of SOM230 s.c. on disease related symptoms (Post-text supplement 3) ? To assess the effect of SOM 230 s.c. on biochemical tumor markers for Nelson?s syndrome, Gonadotroph- adenoma, PRL-adenoma and gastrinoma ? To assess the effect of SOM230 s.c. on tumor response for duodeno-pancreatic (neuro)endocrine tumors (exception: gastrinoma) and TSH- adenoma ? To assess the effect of SOM230 s.c. on Quality of Life (Post-text upplement 2) ? To assess pharmacodynamic effects of SOM230 s.c. at doses of 600 ?g and 900 ?g administered on a b.i.d. schedule 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) ? To assess the single and multiple dose pharmacokinetics of SOM230 s.c. at doses of 600 ?g and 900 ?g administered on a b.i.d. (pls see protocol);Primary end point(s): Primary assessments of activity of SOM230 will be performed with biochemical tumor marker determinations or tumor response, as applicable for each tumor type, which will be collected throughout the study to determine response assessed by tumor marker response at 3 and 6 months. Biochemical tumor marker responses will be defined as good response (>50% decrease from baseline of tumor marker or normalization within normal range), partial response (>20% decrease from basel | — |
Countries
Italy
Outcome results
None listed