Effectiveness of SOM230 In Treating Non-Functioning Pituitary Adenomas

Cedars Sinai Medical Center0 sitesStarted: November 6, 2006Last updated: March 19, 2012

Overview

No summary available.

•Male or postmenopausal female not receiving HRT; Postmenopausal is defined as a minimum of 12 months absence of menorrhoea.
•Age: 18\-80 years
•The patient must have a clinically demonstrable NFT, with no evidence of acromegaly, Cushing’s disease or prolactinoma as demonstrated by normal IGF\-1, normal 24\-hour urinary free cortisol levels and normal to moderately elevated prolactin levels (stalk effect, prolactin \< 200 ng/ml). A screening TRH test must have been performed to confirm possible gonadotroph hypersecretion.
•The patient must have a macroadenoma (\>10mm in widest diameter) demonstrated on MRI performed with and without contrast.
•Patients must have a normal visual field evaluation by Goldman perimetry.
•Hypopituitarism may be present as evidenced by any or all of: a subnormal GH response to Arginine/GHRH testing, low age\-and sex matched IGF\-1 levels, low TSH, free T3 and Free T4, low estradiol, low LH and FSH levels in postmenopausal female patients or low testosterone, LH and FSH levels in male patients, 8 am serum cortisol \< 3µg/dl.
•Patients who are diagnosed with hypopituitarism, will initiate hormone replacement therapy for the 6 month duration of the study, (except for post\-menopausal females) and will be required to discontinue the replacement at the end of 6 months, to re\-evaluate hypopituitarism.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Patients who have had prior surgery, radiotherapy, somatostatin analog or dopamine agonist therapy for their NFT.
•Visual field abnormalities, which will be referred for surgery.
•Evidence of a secretory pituitary tumor as evidenced by elevated IGF\-1, increased 24 hr urinary free cortisol level, or prolactin \>200 ng/ml.
•It is anticipated that the patient may require pituitary surgery or radiotherapy during the study period.
•Clinically significant renal or hepatic abnormalities.
•Active malignant pathology.
•Evidence of drug/alcohol abuse.
•The patient has received any unlicensed drug within 30 days prior to screening.
•Pregnancy (as indicated by serum ß\-HCG pregnancy test, for all female patients with the potential to become pregnant) and patients who are breastfeeding.

Sponsor