Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00171730Other idCSOM230B2201E1Other id2004-002849-12Other id2004

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 30 participants (actual)
Sponsor: Novartis Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 7 countries
United States, Australia, Belgium, France, Germany, Italy, Switzerland
Start: 24 Aug 2004
Primary completion: 6 Dec 2013
Completion: 6 Dec 2013
First posted: 15 Sept 2005 (estimated)
Last update posted: 5 Sept 2021
Conditions: Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200420062008201020122014

Ph 2
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
NCT00171730
24 Aug 2004 to 6 Dec 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PasireotideDrug

Arms1

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).

Primary outcomes1

Outcomes the sponsor listed as primary.

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)
Registry description
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).

Secondary outcomes(5)

Time to Tumor Response
Time frame · Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)
Registry description
Time to tumor response was defined as time from Sandostatin baseline (core study baseline) to at least 20% decrease in tumor volume.
Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes
Time frame · Core study baseline, Months 9, 27, 63, 75 and 99
Registry description
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.
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)
Registry description
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).
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)
Registry description
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.
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)
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (percentage of responders)
Pasireotide s.c. <1200 μg/d	20
Pasireotide s.c. 1200 to <1500 μg/d	28.6
Pasireotide s.c. ≥1500 μg/d	14.3
Pasireotide s.c. Overall	23.1

Secondary and other outcome results(5)

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

Time to Tumor Response

Group	Value (months)
Pasireotide s.c. Overall	12.2

Secondary outcomeMean· Core study baseline, Months 9, 27, 63, 75 and 99

Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes

Group	Value (cubic millimeter (mm))	Spread
Pasireotide s.c. Overall	4457.4	4891.98

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

Percentage of Participants With Symptoms of Acromegaly

Group	Value (percentage of participants)
Pasireotide s.c. Overall	46.7

Secondary outcomeNumber· 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

Group	Value (percentage of participants)
Pasireotide s.c. Overall	36.7

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

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

Group	Value (percentage of participants)
Pasireotide s.c. <1200 μg/d	80.0
Pasireotide s.c. 1200 to <1500 μg/d	86.7
Pasireotide s.c. ≥1500 μg/d	91.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Pasireotide s.c. <1200 μg/dParticipants received pasireotide as a daily 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 μg), with total daily dose \<1200 μg/day with median duration of 2.1 months.	0 / 30	3 / 30	21 / 30
Pasireotide s.c. 1200 to <1500 μg/dParticipants received pasireotide as a daily 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 μg), with total daily dose 1200 to \<1500 μg/day with median duration of 6.4 months.	0 / 30	4 / 30	25 / 30
Pasireotide s.c. ≥1500 μg/dParticipants received pasireotide as a daily 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 μg), with total daily dose ≥ 1500 μg/day with median duration of 16.6 months.	0 / 12	2 / 12	11 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

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Indexing hint: Clinical trial · 2014

Corrected

Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-ended, multicenter, Phase II extension study.

Petersenn et al. 2014Pituitarycited by 33

PMID 23529827PMC3942632DOI 10.1007/s11102-013-0478-0PUB-23529827

CC BY

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Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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