Phase 2
N=30
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT00171730 ↗Enrolled (actual)
30
Serious AEs
12.5%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class — 20; 28.6; 14.3; 23.1 percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pasireotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class |
20; 28.6; 14.3; 23.1 | — |
| SECONDARY Time to Tumor Response |
12.2 | — |
| SECONDARY Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes |
4457.4; 2839.3; 2536; 456; 1016; 180 | — |
| SECONDARY Percentage of Participants With Symptoms of Acromegaly |
46.7; 26.7; 6.7; 0; 0; 20 | — |
| SECONDARY Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation |
36.7; 23.3; 23.3; 0; 16.7; 23.3 | — |
| SECONDARY Percentage of Participants With One or More Adverse Events (AEs) |
80.0; 86.7; 91.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00171730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.