An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly

NCT ID: NCT00171730

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-24
• Study Completion Date: 2013-12-06

Brief Summary

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pasireotide s.c. Overall

Participants received pasireotide as a daily subcutaneous (s.c) injection, every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 microgram (μg)) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).

Group Type: EXPERIMENTAL

Pasireotide

Intervention Type: DRUG

Interventions

Pasireotide

Intervention Type: DRUG

Other Intervention Names

SOM230

Eligibility Criteria

Inclusion Criteria

• Participants who have completed all four treatment regimens in the core study CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide administration at any of the three doses.
• Participants who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201.

Exclusion Criteria

• Participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201.
• Participants who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201.
• Participants who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B2201.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis

Role: STUDY_CHAIR

Novartis

Locations

Cedars Sinai Medical Center Dept. of Pituitary Ctr.

Los Angeles, California, United States

University of Michigan Health System StudyCoordinatorCSOM230B2201E1

Ann Arbor, Michigan, United States

NYU / VA Medical Center

New York, New York, United States

Novartis Investigative Site

Woolloongabba, Queensland, Australia

Novartis Investigative Site

Edegem, , Belgium

Novartis Investigative Site

Toulouse Cédex 4, , France

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Napoli, , Italy

Novartis Investigative Site

Lausanne, , Switzerland

Countries

United States; Australia; Belgium; France; Germany; Italy; Switzerland

References

Petersenn S, Farrall AJ, De Block C, Melmed S, Schopohl J, Caron P, Cuneo R, Kleinberg D, Colao A, Ruffin M, Hermosillo Resendiz K, Hughes G, Hu K, Barkan A. Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-ended, multicenter, Phase II extension study. Pituitary. 2014 Apr;17(2):132-40. doi: 10.1007/s11102-013-0478-0.

Reference Type: RESULT

PMID: 23529827 (View on PubMed)

Other Identifiers

2004-002849-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSOM230B2201E1

Identifier Type: -

Identifier Source: org_study_id