Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly

NCT ID: NCT02396953

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-11-28

Brief Summary

The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lanreotide PRF

One single dose of lanreotide PRF (via subcutaneous injection) either 180mg or 270mg or 360mg.

Group Type: EXPERIMENTAL

Lanreotide PRF

Intervention Type: DRUG

Interventions

Lanreotide PRF

Intervention Type: DRUG

Other Intervention Names

Lanreotide acetate

Eligibility Criteria

Inclusion Criteria

• Documented diagnosis of acromegaly.
• Provided written informed consent prior to any study related procedures.
• Between 18 and 75 years of age inclusive.
• Female of non-childbearing potential or male. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired).
• Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use a medically accepted, effective method of contraception (i.e. condom) for the duration of the study (maximum of 7.5 months).
• Treatment with a stable dose of either octreotide LAR or lanreotide Autogel for at least 3 months immediately prior to study entry, with confirmation of disease control during this treatment period (documentation of age adjusted IGF 1 <1.3 x upper limit of normal (ULN), based on local laboratory results, during screening period).
• If the subject is receiving treatment for hypertension, the dose has been stable for at least 1 month prior to study entry.
• Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow up evaluation as specified in the protocol.

Exclusion Criteria

• Has undergone radiotherapy within 2 years prior to study entry.
• Has been treated with a dopamine agonist and/or GH receptor antagonist or has undergone pituitary surgery within 3 months prior to study entry.
• Is anticipated to require pituitary surgery or radiotherapy during the study.
• Has clinically significant hepatic abnormalities and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥3 x ULN and/or alkaline phosphatase (AP) ≥2.5 x ULN and/or total bilirubin ≥1.5 x ULN and/or gamma-glutamyl transpeptidase (GGT) ≥2.5 x ULN during the Screening period (central laboratory results) or a history of these findings when on somatostatin analogue (SSTa) treatment.
• Has clinically significant pancreatic abnormalities and/or amylase and/or lipase ≥1.5 x ULN during the Screening period (central laboratory results).
• Has any significant renal abnormalities and/or creatinine ≥1.5 x ULN during the screening period (central laboratory results).
• Has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) ≥9%, centrally assessed during the Screening period), or has diabetes treated with insulin for less than 6 months prior to study entry.
• Has any known uncontrolled cardiovascular disease or had any of the following within 6 months of Screening: ventricular or atrial dysrhythmia

≥grade 2, bradycardia ≥grade 2, electrocardiogram (ECG) QT interval corrected (QTc) prolonged ≥grade 2, myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.

• Use of any hormone replacement therapy (HRT) with oestrogens.
• Has symptomatic gallstones/ sludge at the Screening Visit echography (local assessment) OR is asymptomatic but has echography showing clear evidence of impending inflammation such as localised mucosal thickening suggesting the subject is at high risk of developing acute disease. Subjects with asymptomatic gallstones/ sludge and otherwise normal echography may be entered at the discretion of the investigator.
• Has abnormal findings during the Screening period, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety.
• Has been treated with any other investigational medicinal product (IMP) prior to the first study visit without undergoing a washout period of seven times the elimination half-life of the investigational compound.
• Has a known hypersensitivity to any of the test materials or related compounds.
• Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
• Has a history of, or known current, problems with alcohol or drug abuse.
• Has any mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Antwerp University Hospital

Edegem, , Belgium

Domaine Universitaire Sart Tilman

Liège, , Belgium

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Fakultní nemocnice Hradec Králové (University Hospital Hradec)

Hradec Králové, , Czechia

CHU le BOCAGE

Dijon, , France

Hôpital de Bicêtre (AP-HP)

Le Kremlin-Bicêtre, , France

CHU de la Timone

Marseille, , France

Hôpital Haut Lévêque

Pessac, , France

University Medicine Berlin

Berlin, , Germany

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

IRCCS AOU San Martino-IST, University of Genova

Genova, , Italy

Azienda Ospedaliera Padova

Padua, , Italy

Policlinico of Palermo

Palermo, , Italy

Ospedale Cisanello

Pisa, , Italy

Azienda Ospedaliera Universitaria Senese

Siena, , Italy

AO Città della Salute e della Scienza di Torino

Torino, , Italy

Lithuanian University of Health Sciences (LUHS) Kauno klinikos

Kaunas, , Lithuania

Vilnius University hospital Santariskiu Klinikos

Vilnius, , Lithuania

Erasmus University Medical Centre Rotterdam

Rotterdam, , Netherlands

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, , Poland

Szpital Kliniczny im. H. Święcickiego UM w Poznaniu

Poznan, , Poland

Szpital Bielanski im. ks. Jerzego Popieluszki SPZOZ

Warsaw, , Poland

Szpital Kliniczny nr 1

Wroclaw, , Poland

National Institute of Endocrinology

Bucharest, , Romania

Kazan state Medical Academy

Kazan', , Russia

Kemerovo Regional Clinical Hospital

Kemerovo, , Russia

Endocrinological Research Center Ministry of Health Russian Federation

Moscow, , Russia

Healthcare Institution

Nizhny Novgorod, , Russia

Federal State Budgetary Military

Saint Petersburg, , Russia

North-Western State Medical University

Saint Petersburg, , Russia

Hospital Universitario Vall d' Hebron

Barcelona, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Queen Mary, University of London

London, , United Kingdom

Christie NHS Foundation Trust

Manchester, , United Kingdom

Churchill Hospital

Oxford, , United Kingdom

Countries

Belgium; Czechia; France; Germany; Italy; Lithuania; Netherlands; Poland; Romania; Russia; Spain; United Kingdom

References

Neggers S, Badiu C, Biagetti B, Durand-Gasselin L, Petit A, Petrossians P, Regnault B, Rich D, Shafigullina Z, Shustov S, Vydrych A. Pharmacological and safety profile of a prolonged-release lanreotide formulation in acromegaly. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1551-1560. doi: 10.1080/17512433.2021.1986004. Epub 2021 Nov 8.

Reference Type: DERIVED

PMID: 34664531 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-002389-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8-55-52030-309

Identifier Type: -

Identifier Source: org_study_id