An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.

Completed · Phase 3

Conditions studied: Cushing's Disease

In brief

This study provided access to pasireotide sc in patients with Cushing's disease.and provided additional information for safety and efficacy of pasireotide s.c.

Key facts

Study ID: NCT01582061
Run by: Novartis Pharmaceuticals
People needed: 104
Starts: 2011-08-16
Expected to finish: 2017-01-26
Last updated by the study team: 2018-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written informed consent obtained prior to any screening procedures
Male or female patients aged 18 years or greater
Patients with confirmed diagnosis of Cushing's disease as evidenced by mean urinary free cortisol of three 24-hour urine samples collected during the 3-week screening period above the upper limit of the laboratory normal range morning plasma ACTH within the normal or above normal range either MRI confirmation of pituitary adenoma (greater than or equal to 0.6 cm), or inferior petrosal sinus gradient >3 after CRH stimulation for those patients with a microadenoma less than 0.6 cm, or for patients who have had prior pituitary surgery, histopathology confirming an ACTH staining adenoma.
Patients with de novo Cushing's disease must not be considered as candidates for pituitary surgery (i.e. poor surgical candidates, surgically unapproachable tumors, patients with no visible pituitary tumor, patients who refuse to have surgical treatment)
Karnofsky performance status >60 (i.e. requires occasional assistance, but is able to care for most of his personal needs)
For patients on previous medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed
Inhibitors of steroidogenesis (e.g. ketoconazole, metyrapone, rosiglitazone): 1 week
Dopamine agonists (e.g. bromocriptine, cabergoline): 4 weeks
Mitotane: 6 months
Octreotide LAR and Lanreotide autogel: 8 weeks
Lanreotide SR: 4 weeks
Octreotide (immediate release formulation): 1 week
Glucocorticoid receptor inhibitor (mifepristone): 4 weeks

You may not qualify if…

Radiotherapy of the pituitary <4 weeks before screening or patient who has not recovered from side effects
Patients with compression of the optic chiasm causing acute clinically significant visual field defect
Patients with Cushing's syndrome due to ectopic ACTH secretion
Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
Patients who have undergone major surgery within 1 month prior to screening
Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry
QTcF >450 msec at screening
History of syncope or family history of idiopathic sudden death
Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure
Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, concomitant medication(s) with known risk for TdP
Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST more than 2 x ULN, serum creatinine >2.0 x ULN, serum bilirubin >1.5 x ULN, serum albumin < 0.67 x LLN at screening
Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as
History of immunocompromise, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical history will be reviewed
Presence of active or suspected acute or chronic uncontrolled infection
History of, or current alcohol misuse/abuse in the 12 month period prior to screening
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for one month after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with pasireotide
Known hypersensitivity to somatostatin analogues
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
Patients with presence of Hepatitis B surface antigen (HbsAg)
Patients with presence of Hepatitis C antibody test (anti-HCV)

Where it is running

St Josephs Hospital & Medical Center St Joes — Phoenix, Arizona, United States
University of California at Los Angeles UCLA Tiverton — Los Angeles, California, United States
LA Biomedical Research at Harbor UCLA Medical Center — Torrance, California, United States
Emory University School of Medicine — Atlanta, Georgia, United States
John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Diabetes and Endocrinology Associates, PC — Omaha, Nebraska, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
University of New Mexico Hospital UNM — Albuquerque, New Mexico, United States
Mount Sinai School of Medicine — New York, New York, United States
Oregon Health and Science University OHSU 5 — Portland, Oregon, United States
University of Pennsylvania Medical Center Univ Penn — Philadelphia, Pennsylvania, United States
Allegheny Endocrinology Associates — Pittsburgh, Pennsylvania, United States
Mid South Endocrine Associates — Nashville, Tennessee, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Swedish Cancer Institute Swedish Cancer Institute (SC) — Seattle, Washington, United States
Novartis Investigative Site — Fortaleza, Ceará, Brazil
Novartis Investigative Site — Londrina, Paraná, Brazil
Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site — Joinville, Santa Catarina, Brazil
Novartis Investigative Site — São Paulo, São Paulo, Brazil
Novartis Investigative Site — São Paulo, São Paulo, Brazil
Novartis Investigative Site — Prague, Czech Republic, Czechia
Advanced Research, LLC — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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