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

Novartis Pharmaceuticals30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

PasireotideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (10)

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

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

Time to Tumor Response

Time to tumor response was defined as time from Sandostatin baseline (core study baseline) to at least 20% decrease in tumor volume.

Time frame: 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

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.

Time frame: Core study baseline, Months 9, 27, 63, 75 and 99

Percentage of Participants With Symptoms of Acromegaly

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).

Time frame: 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

Data from ClinicalTrials.gov

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