Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

Terminated

• Conditions: Acromegaly

• Registration Number: NCT02698384
• Lead Sponsor: Ipsen

Brief Summary

The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-01
• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Study Completion: 2016-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Male or female aged 18 years or more, suffering from acromegaly
• Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA)
• Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects)
• In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy

Exclusion Criteria

• Subject previously/currently treated with Lanreotide 120mg
• History of radiotherapy for acromegaly
• Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression
• Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists
• Active neoplastic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase.	Month 5

Secondary Outcome Measures

Name	Time	Method
Number of alternative strategies used during the alternative strategy phase	Month 18
Raw values at each visit and change from baseline in the Acromegaly Quality of Life Questionnaire (ACROQoL total score and each dimension) of the monotherapy phase	Baseline, month 5, 12 and 18
Treatments received at least once during the alternative strategy phase	Month 18
Proportion of subjects with clinically relevant tumor shrinkage (tumor volume decrease of ≥ 20% versus V1 (month 0) of the monotherapy phase) at V6 (month 18 time point) of the alternative strategy phase	Month 18
Change in clinical score (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative strategy phase	Month 18
Change in Acromegaly Quality of Life Questionnaire (ACROQoL total score and dimensions) between baseline (month 0) of the monotherapy phase and Month 18 time point of the alternative strategy phase	Month 18
Profile of subjects	Baseline	Description of demographics, Patient-Assessed Acromegaly Symptom Questionnaire (PASQ) clinical score, PASQ overall health status, tumor volume, comorbidities, GH and IGF-1 levels
Achievement of safe concentration of random GH (≤2.5 ng/mL) and normal age- and sex-matched IGF-1 concentrations of the monotherapy phase	Month 12 and 18
Raw values at each visit and change from baseline in random Growth Hormone (GH)	Baseline, month 5, 12 and 18
Proportion of subjects achieving biochemical control (random GH ≤2.5 ng/mL and normal age- and sex-matched IGF-1 concentrations) at month 18 time point of the alternative strategy phase (18 months after the start of the first alternative strategy)	Month 18
History of acromegaly	Baseline	Description of the date of diagnosis, GH and IGF-1 levels and tumor volume at diagnosis
History of treatment	Baseline	Description between the diagnosis of acromegaly and the 1st injection of Lanreotide 120mg (treatments, doses)
Raw values at each visit and change from baseline in overall health status (Patient-Assessed Acromegaly Symptom Questionnaire - PASQ) of the monotherapy phase	Baseline, month 5, 12 and 18
Description of the GH and Insulin-like Growth Factor-1 (IGF-1) levels when the physician decides to start the first alternative strategy	Day 1 (Visit 5)	Assessed in the alternate strategy phase
Change in overall health status (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative phase	Month 18

Trial Locations

Locations (10)

Hopital Larrey; 🇫🇷 Toulouse, France

Hoptial Nord; 🇫🇷 Amiens, France

Hopital Albert Michallon; 🇫🇷 La Tronche, France

Hopital jean Minjoz; 🇫🇷 Besançon, France

Hopital Neuro-Cardiologique, Fédération d'Endocrinologie; 🇫🇷 Bron, France

Hopital Robert Debre; 🇫🇷 Reims, France

Hopital De La Conception; 🇫🇷 Marseille, France

Hopital Nord; 🇫🇷 Saint Etienne, France

Hopital De Hautepierre; 🇫🇷 Strasbourg, France

Hopital Haut Leveque; 🇫🇷 Pessac, France