Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors (NCT02749227) | Clinical Trial Compass
TerminatedPhase 2
Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors
Stopped: Lack of funding
United States4 participantsStarted 2017-07-10
Plain-language summary
This is a phase II, open-label, 12-month pilot study in 10 patients with silent corticotroph pituitary tumors testing the hypotheses that Pasireotide long-acting release (LAR) treatment of patients with silent corticotroph pituitary tumors and elevated plasma Proopiomelanocortin (POMC) levels will reduce plasma POMC levels and this will be associated with a reduction in pituitary tumor size. Pasireotide LAR 40 mg will be administered monthly. Baseline and monthly visits on therapy will monitor plasma levels of POMC, other pituitary function, safety labs, glucose tolerance, physical examination, and visual fields. Pituitary magnetic resonance imaging (MRI) will be done at baseline, 6 months and 12 months of therapy. The eligible patient population will consist of adult patients with known silent corticotroph pituitary tumors and elevated plasma levels of POMC.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Adults (males and females) with a diagnosis of a clinically nonfunctioning pituitary tumor of the silent corticotroph tumor type (i.e., positive adrenocorticotropin (ACTH) staining on immunohistochemical staining of the pituitary tumor obtained at surgery)
✓. Plasma POMC level \> upper limit of normal
✓. Prior pituitary tumor surgery with residual or recurrent pituitary tumor visible on MRI scan that is ≥ 5 mm from the optic chiasm.
✓. Surgical resection of the pituitary adenoma must have occurred two or more months prior to enrollment
✓. If patients have undergone pituitary radiotherapy they must have completed their course of radiotherapy at least 2 months prior to study screening
✓. No prior somatostatin analog therapy
✓. No concurrent use of dopamine agonist therapy
✓. No active malignancy
Exclusion criteria
✕. Patients with Cushing's disease (biochemical evidence of hypercortisolism)
What they're measuring
1
Change in Plasma Proopiomelanocortin (POMC) Levels
✕. Patients with compression of the optic chiasm causing any visual field defect that requires surgical intervention
✕. Diabetic patients with poor glycemic control as evidenced by HbA1c \>8%
✕. Patients who are hypothyroid or adrenally insufficient and not on adequate replacement therapy
✕. Patients with symptomatic cholelithiasis and acute or chronic pancreatitis
✕. Patients with risk factors for torsade de pointes, i.e., patients with a baseline QTcF (Fridericia's Correction Formula value) \>450 ms in males, and \>460 ms in females
✕. Hypokalaemia, hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome or concomitant medications with known risk of Torsades de pointes (TdP). Drugs with possible risk of TdP should be avoided whenever feasible
✕. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute myocardial infarction (MI) less than one year prior to study entry or clinically significant impairment in cardiovascular function