An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly (ACCESS)

• ClinicalTrials.gov Identifier: NCT01995734
• Expanded Access Status: Approved for marketing
• First Posted: November 27, 2013
• Last Update Posted: December 29, 2015
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: November 20, 2013
• First Posted Date: November 27, 2013
• Last Update Posted Date: December 29, 2015

Descriptive Information

• Brief Title: An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Expanded Access

Intervention

Drug: Pasireotide long acting release formulation

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.

Other Name: SOM230 LAR

Publications *

• 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.
• 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. pii: bcr-2017-219686. doi: 10.1136/bcr-2017-219686.
• 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.
• 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.

Recruitment Information

• Expanded Access Status: Approved for marketing
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01995734
• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: December 2015