Clinical trial NCT00171730: An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Official title: Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acromegaly
Keywords: Acromegaly
Pasireotide
GH
IGF-1
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class
timeFrame: Month 9 (Month 9 visit is at the completion of six months in this extension study)
Secondary outcomes:
measure: Time to Tumor Response
timeFrame: Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)
measure: Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes
timeFrame: Core study baseline, Months 9, 27, 63, 75 and 99
measure: Percentage of Participants With Symptoms of Acromegaly
timeFrame: Core study baseline till the last assessment of the extension study (up to approximately 114 months)
measure: Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation
timeFrame: Core study baseline till the last assessment of the extension study (up to approximately 114 months)
measure: Percentage of Participants With One or More Adverse Events (AEs)
timeFrame: From start of study drug treatment up to end of study (approximately 111 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Dept. of Pituitary Ctr.
state: California
city: Ann Arbor
country: United States
facility: University of Michigan Health System StudyCoordinatorCSOM230B2201E1
state: Michigan
city: New York
country: United States
facility: NYU / VA Medical Center
state: New York
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Toulouse Cédex 4
country: France
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: 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.