PASPORT Cushing’s, part of the PASPORT clinical trial research program, will further evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease. These studies are designed as registration trials for pasireotide LAR in Cushing’s disease. Pasireotide LAR is approved for Cushing's Disease.
Novartis is conducting registration trials of pasireotide in patients with these types of tumors.
Key Inclusion Criteria:
Patients with persistent or recurrent disease or de novo Cushing’s disease who are
nonsurgical candidates
Adult patients with confirmed ACTH-dependent Cushing’s disease
Baseline mUFC levels ≥1.5 x ULN and ≤5 x ULN
Morning plasma ACTH within or above the normal range
Confirmation of pituitary adenoma or positive inferior petrosal sinus gradient
Histopathological confirmation of an ACTH-staining adenoma in postsurgical patients
Patients with a KP status ≥60
Key Exclusion Criteria:
Patients who have received pasireotide prior to enrollment
Patients who received pituitary irradiation within the last 10 years, have been
treated with mitotane within the last 6 months, or are hypothyroid and not on
adequate replacement therapy
Patients with
Compression of the optic chiasm causing significant visual field defects
Cushing’s syndrome due to ectopic ACTH secretion
Hypercortisolism secondary to adrenal tumors or adrenal hyperplasia
An inherited syndrome responsible for hormone oversecretion
Glucocorticoid-remedial aldosteronism
Patients with known hypersensitivity to somatostatin analogues or any components of LAR formulation
To find out more about this Cushing's Disease clinical trial, Click here
Key Inclusion Criteria:
Adult patients with a confirmed diagnosis of Cushing's disease
Mean UFC above ULN
Morning plasma ACTH with in or above the normal range
MRI confirmation of pituitary adenoma (≥0.6 cm) or positive inferior petrosol sinus gradient for patients with a microadenoma <0.6 cm
Histopathological confirmation of an ACTH-staining adenoma in postsurgical patients
Patients with de novo Cushing’s disease who are nonsurgical candidates
Patients with a KP status >60
Key Exclusion Criteria:
Patients who received radiotherapy of the pituitary <4 weeks before screening or who have not recovered from side effects
Patients with
Compression of the optic chiasm causing significant visual field defects
Cushing’s syndrome due to ectopic ACTH secretion
Hypercortisolism secondary to adrenal tumors or adrenal hyperplasia
An inherited syndrome responsible for hormone oversecretion
Glucocorticoid-remedial aldosteronism
Patients with known hypersensitivity to somatostatin analogues
Patients who have received pasireotide prior to enrollment
Abbreviations: ACTH=adrenocorticotropic hormone; AEs=adverse events; bid=twice a day; FPFV=first patient first visit; KP=Karnofsky Performance; MRI=magnetic resonance imaging; SC=subcutaneous;UFC=urinary-free cortisol;
ULN=upper limit of normal
To find out more about this Cushing's Disease clinical trial, Click here
