- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171730
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
September 1, 2021 updated by: Novartis Pharmaceuticals
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Novartis Investigative Site
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Edegem, Belgium, 2650
- Novartis Investigative Site
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Toulouse Cédex 4, France, 31043
- Novartis Investigative Site
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Essen, Germany, 45122
- Novartis Investigative Site
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Muenchen, Germany, 80336
- Novartis Investigative Site
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Napoli, Italy, 80131
- Novartis Investigative Site
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Lausanne, Switzerland, 1011
- Novartis Investigative Site
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California
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center Dept. of Pituitary Ctr.
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System StudyCoordinatorCSOM230B2201E1
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New York
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New York, New York, United States, 10010
- NYU / VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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).
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class
Time Frame: Month 9 (Month 9 visit is at the completion of six months in this extension study)
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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).
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Month 9 (Month 9 visit is at the completion of six months in this extension study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Tumor Response
Time Frame: Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)
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Time to tumor response was defined as time from Sandostatin baseline (core study baseline) to at least 20% decrease in tumor volume.
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Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)
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Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes
Time Frame: Core study baseline, Months 9, 27, 63, 75 and 99
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Pituitary Tumor Volumes were assessed by MRI.
Core study baseline was defined as the last non-missing observation prior to the start of Sandostatin s.c.
treatment.
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Core study baseline, Months 9, 27, 63, 75 and 99
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Percentage of Participants With Symptoms of Acromegaly
Time Frame: Core study baseline till the last assessment of the extension study (up to approximately 114 months)
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Participants scored the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0 = None/absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe).
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Core study baseline till the last assessment of the extension study (up to approximately 114 months)
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Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation
Time Frame: Core study baseline till the last assessment of the extension study (up to approximately 114 months)
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Sleep apnea symptoms were assessed using the Epworth Sleepiness Scale (ESS).
The ESS is a self-administered questionnaire with 8 questions.
It provides a measure of a person's general level of daytime sleepiness, or average sleep propensity in daily life.
Percentage of participants were reported in 8 different situations: sitting and reading; watching TV; sitting, inactive in a public place; passenger in a car, an hour without break; lying down to rest in the afternoon; sitting and talking to someone; sitting quietly after a lunch without alcohol; and in a car, stopped a few minutes in the traffic.
The participants were rated: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing.
Higher scores indicate more severe daytime sleepiness.
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Core study baseline till the last assessment of the extension study (up to approximately 114 months)
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Percentage of Participants With One or More Adverse Events (AEs)
Time Frame: From start of study drug treatment up to end of study (approximately 111 months)
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An AE was any undesirable sign, symptom or medical condition that occurred after starting study drug even if the event was not considered to be related to study drug.
Percentage of participants with any AE were categorized by pasireotide incident dose classes, which were defined by total daily doses ranges (<1200 μg/d, 1200 to <1500 μg/d, ≥ 1500 μg/d).
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From start of study drug treatment up to end of study (approximately 111 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 24, 2004
Primary Completion (ACTUAL)
December 6, 2013
Study Completion (ACTUAL)
December 6, 2013
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 1, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Hyperpituitarism
- Pituitary Diseases
- Acromegaly
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Pasireotide
Other Study ID Numbers
- CSOM230B2201E1
- 2004-002849-12 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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