non-functioning pitiutary adenomes MedDRA version: 9.1 Level: LLT Classification code 10035079 Term: Pituitary adenoma
Conditions
Interventions
Product Name: SOM230
Pharmaceutical Form: Injection*
Current Sponsor code: SOM230
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 300-
Sponsors
Cedars Sinai Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: NFTs express somatostatin receptors. In vitro, octreotide suppresses intact and glycoprotein subunit secretion from dispersed NFT cells. Although, octreotide has not been effective in vivo, this somatostatin analog binds preferrentially to SSTR2. We propose that SOM230, which binds to all the somatostatin receptor subtypes with high affinity, may be more effective in shrinking the tumor bulk. Study objective is to evaluate the rate of patients responding to SOM230 after 6 months of treatment or during the 6 months treatment period. Response is defined as a decrease of at least 25% decrease in tumor size as compared to baseline. ;Secondary Objective: ;Primary end point(s): Tumor size: measured by MRI at 0 and 6 months, and 1 month after treatment is discontinued. Macroadenoma is defined as a tumor > 10 mm diameter on MRI. Tumor extension will be recorded as intrasellular, suprasellar or “other extension’ if there is evidence of spread beyond the immediate sellar region eg into the adjacent cavernous sinus (Gittoes, Clin Endo, 1994). In defining response criteria of tumor shrinkage there is no published data on tumor volume response of NFT to medical therapy. The following volume responses will be used based on volume responses observed in GH secreting adenomas in acromegalic patients on medical therapy. A 25% decrease in volume will be regarded as clinically relevant based on analysis of GH secreting tumor responses to octreotide in the following published studies: Primary Medical Therapy and Significant Tumor Size Reduction (>25%) Octreotide SC (Lundin) 11/17 Octreotide SC (Newman) 3/13 Octreotide LAR Depot (Colao) 10/15 Lanreotide (Baldelli) 5/23 Lanreotide (Cozzi) 5/5 Octreotide LAR Depot (Beven) 18/24 Success of the study will be determined depending on the number of patients responding to treatment. Number of patients responding will be classified as: small if >/= 30% patients experience a 25% reduction, moderate if 30-60% of patients ex | — |
Countries
Germany
Outcome results
None listed