AcromegalyPhase 3PRIMARYSNCT00690898
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
A Phase 3 study testing Lanreotide autogel 120 mg in people with Acromegaly, run by Ipsen at 27 sites in 9 countries.
Trial summary
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland. The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Lanreotide autogel 120 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 27 sitesin 9 countries
- Study dates
- May 2008to Feb 2012
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has given written informed consent prior to any study related procedures
- The patient is male or female and is aged between 18 and 75 years, inclusive,
- Diagnosis of acromegaly defined by i) GH nadir > 1 ng/mL as assessed by an oral glucose tolerance test for non diabetic patients (central laboratory results) or a mean GH level > 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the age- and sex-matched normal range for diabetic and non diabetic patients (central laboratory results),
- The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading,
- The patient has no visual field defect identified at the visual evaluation, performed by Goldman Visual Fields Analyser and Automated visual field static perimeter, except visual field abnormality at the time of screening and that is in the investigator's Clinical judgement:
- Not related to the pituitary adenoma
- Clinically stable condition not presumed to change during the study period
- Not modifying the ability to evaluate visual field changes related to the macroadenoma
Who cannot join
- The patient has a history of hypersensitivity to Lanreotide or drugs with a similar chemical structure,
- The patient has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study,
- The patient is likely to require treatment during the study with somatostatin analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the study protocol,
- The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive methods. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,
- The patient is pregnant or lactating,
- The patient has a history of, or known current, problems with alcohol abuse,
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- The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study,
- The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry,
- The patient has previously been treated with a somatostatin analogue,
- The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant) prior to study entry,
- The patient is expected to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period,
- Patients with suspected associated prolactinoma: prolactin level > 100 ng/mL (central laboratory results),
- Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2),
- Patient known by Investigator, to have congenital or acquired optic nerve disease or any visual abnormality with risk of worsening during the course of the study (e.g glaucoma), influencing ability to evaluate Visual Field changes related to the macroadenoma.
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
France9 sites
Hopital De Bois Guillaume
Bois-Guillaume, 76230 Cedex
CHU Henri Mondor
Créteil, 94010
CHU Grenoble Albert Michallon
Grenoble, 38043 Cedex
CHRU Lille Hopital Claude Huriez
Lille
Groupement Hospitalier Est
Lyon, 69677 Bron Cedex
Hôpital de la Timone
Marseille, 13385
Hôpital Bicêtre
Paris, 94275 Cedex
Hopital Haut Leveque
Pessac, 33604 Cedex
CHU de Reims, Hopital Robert Debré
Reims
Germany5 sites
Friedrich-Alexander University
Erlangen, 91054
Universitatsklinikum Essen
Essen, 45122
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, 60590
ENDOC Zentrum für Endokrine Tumoren und Praxis für Endokrinologie, Andrologie und medikamentöse Tumortherapie
Hamburg, 20357
Medizinische Klinik Innenstadt
München, 80336
Italy3 sites
AOU Policlinico "G. Martino" Messina
Messina, 98125
Università Federico II di Napoli, Dipartimento di Endocrinologia Molecolare e Clinicae Oncologia
Naples, 5 80131
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, U.O.C. di Endocrinologia
Roma, 00168
United Kingdom3 sites
27/28 Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Christie Hospital
Manchester, M20 4BX
Derriford Hospital
Plymouth, PL6 8DH
Finland2 sites
Helsinki University Center Hospital
Helsinki, 9 FIN-00290
The Turku University Central Hospital
Turku, 20520
Netherlands2 sites
ERASMUS MC Rotterdam
Rotterdam, 3000
UMC Utrecht
Utrecht, 3508
Czechia1 site
Všeobecná fakultní nemocnice, Karlova Univerzita
Prague, 128 08 Praha 2
About this study
Official title: Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.
The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.
Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.
- Conditions
- Acromegaly
- Being tested
- Lanreotide autogel 120 mg
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide autogel 120 mgDrug
12 months
| Study group | Role | What they receive |
|---|---|---|
| Lanreotide autogel 120 mg | Experimental | Not described Receives: Drug: Lanreotide autogel 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)
A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.
Measured: Week 1 and Week 48
Secondary outcomes (10)
Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).
Measured: Baseline (week 1) to week 12 and week 24
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels
Measured: Week 12, 24, and 48
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.
Measured: Week 12, 24, and 48
Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels
Measured: Week 12, 24 and 48
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Measured: Week 12, 24 and 48
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Measured: Week 12, 24 and 48
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Measured: Week 12, 24 and 48
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Measured: Week 12, 24 and 48
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Measured: Week 12, 24 and 48
Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline
Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
Measured: Week 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690898
- Sponsor's protocol ID
- 2-79-52030-207
- Other IDs
- 2007-000155-34
- Acronym
- PRIMARYS
- Status last verified
- Sep 2022
- First submitted
- 3 Jun 2008
- Last updated
- 14 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
Caron PJ, Bevan JS, Petersenn S, Flanagan D, Tabarin A, Prevost G, Maisonobe P, Clermont A; PRIMARYS Investigators. Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial. J Clin Endocrinol Metab. 2014 Apr;99(4):1282-90. doi: 10.1210/jc.2013-3318. Epub 2013 Jan 1.
PubMed 24423301Caron PJ, Bevan JS, Petersenn S, Houchard A, Sert C, Webb SM; PRIMARYS Investigators Group. Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study. Pituitary. 2016 Apr;19(2):149-57. doi: 10.1007/s11102-015-0693-y.
PubMed 26603536