Prolactinoma MedDRA version: 9.1 Level: LLT Classification code 10036832 Term: Prolactinoma
Conditions
Sponsors
Universitätsklinikum Essen - Zentrum für Innere Medizin - Klinik für Endokrinologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients • Age: 18 – 80 years • Patients with Prolactinomas as shown by: - increased serum levels of Prolactin > 150 ng/ml and - confirmation of tumor lesion by MRT • A wash-out phase for non de novo patients with the following timeframes: - Bromocriptine: 7 days - Quinagolide: 7 days - Cabergoline: 14 days •Women of childbearing potential must use effective contraception during the study and for three months after study completion. A contraceptive method is considered effective when its failure rate is less than 1% per year (Pearl Index (PI)). Contraception must consist of either double-barrier contraception, oral contraceptive plus barrier contraceptive or clinically documented total hysterectomy and/or oophorectomy or tubal ligation. Postmenopausal females must show amenorrhea for at least 12 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
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 • Pregnancy or breast-feeding • Known immunosuppression • Hyperprolactinemia due to any other cause (e.g. anti-depressive drugs) • Patients with risk factors for Torsade de Pointes (QT > 470 ms on screening ECG, hypokalaemia, familiar history of a Long-QT-Syndrome or concomitant medication known to prolong the QT interval) •Heart failure (NYHA II-IV) • Other malignant diseases, except Basalioma or in situ Cervix carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to evaluate the rate of patients responding to a dose of 600 and 900 µg Pasireotide (SOM230), given in a randomized order within two consecutive days, that is within 48 h. Response is defined as a minimal 25% decrease of the primarily elevated Prolactin values. A cross-over study design was chosen to discriminate between the potential effects of different doses of Pasireotide (600 µg, 900 µg, or the sum of both) on serum Prolactin levels.;Secondary Objective: • Mean decrease of Prolactin in serum • Dose-dependency of any effect • Safety and tolerance of the Pasireotide administration • PK-/PD-analysis • Correlation of clinical response and receptor status as determined by quantitative reverse real time PCR and immunohistochemistry whenever material is available. ;Primary end point(s): Percentage of patients, who show an at least 25% decrease of the primarily elevated Prolactin values in serum samples within 10 hours after the administration of 600 or 900 µg Pasireotide. | — |
Countries
Germany
Outcome results
None listed