Clinical trial NCT02698384: Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg
Official title: Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acromegalic subjects

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Month 5
Secondary outcomes:
measure: Profile of subjects
timeFrame: Baseline
measure: History of acromegaly
timeFrame: Baseline
measure: History of treatment
timeFrame: Baseline
measure: Achievement of safe concentration of random GH (≤2.5 ng/mL) and normal age- and sex-matched IGF-1 concentrations of the monotherapy phase
timeFrame: Month 12 and 18
measure: Raw values at each visit and change from baseline in random Growth Hormone (GH)
timeFrame: Baseline, month 5, 12 and 18
measure: Raw values at each visit and change from baseline in overall health status (Patient-Assessed Acromegaly Symptom Questionnaire - PASQ) of the monotherapy phase
timeFrame: Baseline, month 5, 12 and 18
measure: 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
timeFrame: Baseline, month 5, 12 and 18
measure: Description of the GH and Insulin-like Growth Factor-1 (IGF-1) levels when the physician decides to start the first alternative strategy
timeFrame: Day 1 (Visit 5)
measure: 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)
timeFrame: Month 18
measure: Number of alternative strategies used during the alternative strategy phase
timeFrame: Month 18
measure: Treatments received at least once during the alternative strategy phase
timeFrame: Month 18
measure: 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
timeFrame: Month 18
measure: Change in clinical score (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative strategy phase
timeFrame: Month 18
measure: Change in overall health status (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative phase
timeFrame: Month 18
measure: 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
timeFrame: Month 18
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hoptial Nord
city: Besançon
country: France
facility: Hopital jean Minjoz
city: Bron
country: France
facility: Hopital Neuro-Cardiologique, Fédération d'Endocrinologie
city: La Tronche
country: France
facility: Hopital Albert Michallon
city: Marseille
country: France
facility: Hopital De La Conception
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Reims
country: France
facility: Hopital Robert Debre
city: Saint Etienne
country: France
facility: Hopital Nord
city: Strasbourg
country: France
facility: Hopital De Hautepierre
city: Toulouse
country: France
facility: Hopital Larrey
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: