Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

Acromegaly Clinical Trial

— ACRO-OPTIM  

Official title:

Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02698384
• Other study ID #: A-54-52030-315
• Status: Terminated
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: December 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
France	Hoptial Nord	Amiens
France	Hopital jean Minjoz	Besançon
France	Hopital Neuro-Cardiologique, Fédération d'Endocrinologie	Bron
France	Hopital Albert Michallon	La Tronche
France	Hopital De La Conception	Marseille
France	Hopital Haut Leveque	Pessac
France	Hopital Robert Debre	Reims
France	Hopital Nord	Saint Etienne
France	Hopital De Hautepierre	Strasbourg
France	Hopital Larrey	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Profile of subjects	Description of demographics, Patient-Assessed Acromegaly Symptom Questionnaire (PASQ) clinical score, PASQ overall health status, tumor volume, comorbidities, GH and IGF-1 levels	Baseline
Secondary	History of acromegaly	Description of the date of diagnosis, GH and IGF-1 levels and tumor volume at diagnosis	Baseline
Secondary	History of treatment	Description between the diagnosis of acromegaly and the 1st injection of Lanreotide 120mg (treatments, doses)	Baseline
Secondary	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
Secondary	Raw values at each visit and change from baseline in random Growth Hormone (GH)		Baseline, month 5, 12 and 18
Secondary	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
Secondary	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
Secondary	Description of the GH and Insulin-like Growth Factor-1 (IGF-1) levels when the physician decides to start the first alternative strategy	Assessed in the alternate strategy phase	Day 1 (Visit 5)
Secondary	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
Secondary	Number of alternative strategies used during the alternative strategy phase		Month 18
Secondary	Treatments received at least once during the alternative strategy phase		Month 18
Secondary	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
Secondary	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
Secondary	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
Secondary	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