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

NCT00171730 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CSOM230B2201E12004-002849-12
• Study Type: interventional
• Target: 30
• Locations: 7 countries
• Sites: 10

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

Keywords

Acromegaly; Pasireotide; GH; IGF-1

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class

  A participant was a responder to a dose level if the mean GH level after dosing (t30, t60, t90, and t120) was below/equal to 2.5 microgram/litre (μg/L), and if the mean of IGF-1 of the two pre-dose values (t-30, t-1) was within normal limits for age-sex matched controls. If three or more of t30, t60, t90, or t120 were missing, mean GH was considered missing. If either t-30 or t-1 was missing, mean IGF-1 was considered missing. Pasireotide incident dose classes were defined by total daily doses ranges (\<1200 μg/d, 1200 to \<1500 μg/d, ≥ 1500 μg/d).

  Month 9 (Month 9 visit is at the completion of six months in this extension study)

Secondary Outcomes (5)

• Time to Tumor Response

  Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)

• Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes

  Core study baseline, Months 9, 27, 63, 75 and 99

• Percentage of Participants With Symptoms of Acromegaly

  Core study baseline till the last assessment of the extension study (up to approximately 114 months)

• Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation

  Core study baseline till the last assessment of the extension study (up to approximately 114 months)

• Percentage of Participants With One or More Adverse Events (AEs)

  From start of study drug treatment up to end of study (approximately 111 months)

Study Arms (1)

Pasireotide s.c. Overall

EXPERIMENTAL

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).

Drug: Pasireotide

Interventions

Pasireotide DRUG

Also known as: SOM230

Pasireotide s.c. Overall

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Cedars Sinai Medical Center Dept. of Pituitary Ctr.

Los Angeles, California, 90048, United States

Location

University of Michigan Health System StudyCoordinatorCSOM230B2201E1

Ann Arbor, Michigan, 48109, United States

Location

NYU / VA Medical Center

New York, New York, 10010, United States

Location

Novartis Investigative Site

Woolloongabba, Queensland, 4102, Australia

Location

Novartis Investigative Site

Edegem, 2650, Belgium

Location

Novartis Investigative Site

Toulouse Cédex 4, 31043, France

Location

Novartis Investigative Site

Essen, 45122, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23529827 RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: August 24, 2004
• Primary Completion: December 6, 2013
• Study Completion: December 6, 2013
• Last Updated: September 5, 2021
• Results First Posted: June 2, 2021

Record last verified: 2021-09

Locations

FR (1); CH (1); AU (1); US (3); DE (2); BE (1); IT (1)