Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00690898
• Date of registration: 03/06/2008
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma PRIMARYS
• Scientific 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
• Date of first enrolment: May 2008
• Target sample size: 108
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00690898
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Czech Republic, Czechia, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Turkey, United Kingdom

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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,

- 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acromegaly

Intervention(s)

Drug: Lanreotide autogel 120 mg

Primary Outcome(s)

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) [Time Frame: Week 1 and Week 48]

Secondary Outcome(s)

Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels [Time Frame: Week 12, 24 and 48]

Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels. [Time Frame: Week 12, 24, and 48]

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). [Time Frame: Baseline (week 1) to week 12 and week 24]

Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline [Time Frame: Week 12, 24 and 48]

Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels [Time Frame: Week 12, 24, and 48]

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline [Time Frame: Week 12, 24 and 48]

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline [Time Frame: Week 12, 24 and 48]

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline [Time Frame: Week 12, 24 and 48]

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline [Time Frame: Week 12, 24 and 48]

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline [Time Frame: Week 12, 24 and 48]

Secondary ID(s)

2-79-52030-207

2007-000155-34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/12/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00690898