Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-08 @ 6:37 AM
Study NCT ID:
NCT01995734
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2015-12-29
First Post:
2013-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-26', 'studyFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acromegaly, Pituitary diseases'], 'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '30899469', 'type': 'DERIVED', 'citation': 'Jerkins TW, Jerkins RK, Franklin R. Successful debulking of plurihormonal pituitary macroadenoma with long-acting pasireotide and dopamine agonist combination therapy. Clin Case Rep. 2019 Jan 28;7(3):445-451. doi: 10.1002/ccr3.1961. eCollection 2019 Mar.'}, {'pmid': '29925553', 'type': 'DERIVED', 'citation': 'Lovato CM, Kapsner PL. Analgesic effect of long-acting somatostatin receptor agonist pasireotide in a patient with acromegaly and intractable headaches. BMJ Case Rep. 2018 Jun 19;2018:bcr2017219686. doi: 10.1136/bcr-2017-219686.'}, {'pmid': '28025627', 'type': 'DERIVED', 'citation': 'Gordon MB, Nakhle S, Ludlam WH. Patients with Acromegaly Presenting with Colon Cancer: A Case Series. Case Rep Endocrinol. 2016;2016:5156295. doi: 10.1155/2016/5156295. Epub 2016 Nov 29.'}, {'pmid': '27896545', 'type': 'DERIVED', 'citation': 'Fleseriu M, Rusch E, Geer EB; ACCESS Study Investigators. Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study. Endocrine. 2017 Jan;55(1):247-255. doi: 10.1007/s12020-016-1182-4. Epub 2016 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory approval for pasireotide is sought.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed diagnosis of active acromegaly with elevated IGF-1 (\\>ULN) and random GH (\\>1 μg/L) within 30 days of screening.\n* Patients who are not controlled by pituitary surgery or who are not eligible for or refuse surgery.\n* For patients on medical treatment for acromegaly the following washout periods must be completed before screening assessments are performed:\n\n * Dopamine agonists (bromocriptine, cabergoline): 4 weeks\n * GH-receptor antagonists (pegvisomant): 8 weeks\n * Somatostatin analogues: no washout period required\n* Karnofsky performance status ≥ 60.\n\nExclusion Criteria:\n\n* Concomitant treatment with somatostatin analogues unless concomitant treatment was discontinued 28 days before first pasireotide LAR injection is administrated.\n* Concomitant treatment with growth hormone receptor (GHR)-antagonists or dopamine agonists unless concomitant treatment was discontinued and the washout period was completed before the screening assessments are performed.\n* Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.\n* Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression.\n* Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of screening.\n* Patients who have received radiotherapy of the pituitary within 4 weeks prior to screening or have not recovered from side effects of radiotherapy.\n* Patients who have a history of hypothyroidism and who are not adequately treated with stable doses of thyroid hormone replacement therapy.\n* Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix).\n* Diabetic patients whose blood glucose is poorly controlled.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01995734', 'acronym': 'ACCESS', 'briefTitle': 'An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An ACromegaly, Open-label, Multi-CEnter, Safety Monitoring Program for Treating Patients With SOM230 (Pasireotide) LAR Who Have Need to Receive Medical Therapy (ACCESS)', 'orgStudyIdInfo': {'id': 'CSOM230CUS33'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pasireotide long acting release formulation', 'type': 'DRUG', 'otherNames': ['SOM230 LAR'], 'description': 'Pasireotide LAR will be administered intramuscularly (i.m.) every 28 days until pasireotide becomes commercially available and reimbursed or until 31 December 2015, whichever occurs first.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Univ. of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Advanced Research, LLC Advanced Reserch (4)', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital Medical Center St. Joseph's Hosp Med Ctr (2)", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Coastal Endocrinology Group', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles UCLA - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "John Wayne Cancer Institute Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': "Harbor-UCLA Medical Center Center for Men's Health", 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Center Medical Faculty Associates Inc', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Diabetes & Endocrine Care Dept.of Ctr for Diab&Endoc - 2', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Endocrine & Diabetes Consultants', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Endocrine Assoc of FL', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine/Winship Cancer Institute Emory University (5)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31901', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dr. Steven Leichter, Endocrine Consultant', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60611-3308', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Endo, Metabolism and Molecular', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University School of Medicine Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore Sinai Hospital, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center Tufts Medical Ctr', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - 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