Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone
1 other identifier
interventional
125
10 countries
24
Brief Summary
The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2006
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 2, 2006
CompletedFirst Posted
Study publicly available on registry
October 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 23, 2018
CompletedSeptember 27, 2022
September 1, 2022
2 years
October 2, 2006
September 14, 2017
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period
Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at Visit (V) 1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to investigational medicinal product (IMP) administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period are presented. The last observation carried forward (LOCF) was used to replace missing IGF-1 values.
V3 (Week 12; Baseline) up to V11 (Week 44)
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant
Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by previous treatment and by final pegvisomant dose are presented. The denominator used to calculate percentages was the number of subjects in each subgroup, comprising previous treatment with pegvisomant, lanreotide Autogel and octreotide long acting repeatable (LAR) and final pegvisomant dose as either 40 mg, 60 mg or 80 mg once a week or 40 mg or 60 mg twice per week. The LOCF approach was used to replace missing IGF-1 values.
V3 (Week 12; Baseline) up to V11 (Week 44)
Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Diabetic Status at Baseline
Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by diabetic status are presented. The denominator used to calculate percentages was the number of subjects in each subgroup (diabetic and non diabetic). The LOCF approach was used to replace missing IGF-1 values.
V3 (Week 12; Baseline) up to V11 (Week 44)
Secondary Outcomes (22)
Percentage of Subjects With a Normalised (Age and Sex Adjusted) IGF-1 Level at Any Time During the Co-administration Period
V3 (Week 12; Baseline) up to V11 (Week 44)
Percentage of Subjects With Normalised (Age and Sex Adjusted) IGF-1 at Each Assessment
V1 (Screening) up to V11 (Week 44)
Change From Baseline in Serum IGF-1 Levels (Expressed as Z-scores) During the Co-administration Period
V3 (Week 12; Baseline) up to V11 (Week 44)
Change From Baseline in Acromegaly Symptoms During the Co-administration Period
V3 (Week 12; Baseline) up to V11 (Week 44)
Change From Baseline in Acromegaly Quality of Life (ACROQoL) Assessments During the Co-administration Period
V3 (Week 12; Baseline) up to V11 (Week 44)
- +17 more secondary outcomes
Other Outcomes (5)
Change From Baseline in Serum GH Levels During the Co-administration Period
V3 (Week 12; Baseline) up to V11 (Week 44)
Percentage of Subjects With Serum GH Levels Lesser or Equal to 2.5 ng/mL During the Study
V3 (Week 12; Baseline) up to V11 (Week 44)
Change From Baseline in Serum GH Binding Protein Levels During the Co-administration Period
V3 (Week 12; Baseline) up to V11 (Week 44)
- +2 more other outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.
Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.
Eligibility Criteria
You may qualify if:
- The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels
- The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN when treated with somatostatin analogue, on a daily basis for at least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above the upper limit of normal (ULN) after treatment with pegvisomant 30 mg per day, OR the patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months including 3 months at the highest marketed dose and has a serum IGF-1 level above ULN, 28 days after the last injection
- At the end of the run-in period, The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir \> 1 µg/L (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg OR the patient is diabetic and has a serum IGF-1 level above 1.2 ULN, 28 days after the 3rd injection of lanreotide Autogel 120 mg
You may not qualify if:
- The patient has undergone pituitary surgery or radiotherapy within 6 months prior to study entry, or it is anticipated that it will be done during the study
- The patient has already been treated with a somatostatin analogue associated with a GH antagonist
- The patient has received dopamine agonist within 6 weeks prior to the study entry
- The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT, alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN)
- The patient is at risk of pregnancy or is lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (24)
University Hospital, Charles University
Hradec Králové, 500 05, Czechia
Charles University
Prague, 120 00 PRAHA 2, Czechia
Aarhus Kommunehospital
Aarhus, Denmark
Groupe Hospitalier Henri Mondor- Albert Chenevier
Créteil, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
Clinique Marc Linquette
Lille, 59037, France
Hôpital de la Timone
Marseille, 13385, France
CHU de Rangueil
Toulouse, 31054, France
Charite Campus Mitte
Berlin, 10117, Germany
Klinikum Johann Wolfgang Goethe-Universität
Frankfurt, 605090, Germany
Medizinische Klinik Innenstadt
München, 80336, Germany
Anticancer Hospital Metaxa Piraeus
Piraeus, 18537, Greece
Universitá degli Studi di Milano
Milan, 20122, Italy
University Federico II
Napoli, 80131, Italy
Universitá di Torino
Torino, 10126, Italy
Leiden University Medical Center
Leiden, 2300 RC, Netherlands
Dept. of Internal Medicine Erasmus MC
Rotterdam, 3015 GD, Netherlands
Hospital General de Alicante
Alicante, 03012, Spain
Clínica Puerta de Hierro
Madrid, 28035, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Uppsala University Hospital
Uppsala, 75185, Sweden
Christie Hospital and Holt Radium Institute
Manchester, M20 4BX, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Related Publications (1)
van der Lely AJ, Bernabeu I, Cap J, Caron P, Colao A, Marek J, Neggers S, Birman P. Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone. Eur J Endocrinol. 2011 Mar;164(3):325-33. doi: 10.1530/EJE-10-0867. Epub 2010 Dec 10.
PMID: 21148630RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Endocrinology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2006
First Posted
October 3, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
September 27, 2022
Results First Posted
July 23, 2018
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.