Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg (ACRO-OPTIM)

Ipsen

Status: Terminated

Conditions: Acromegaly

Study type: Observational

Funder types: Industry

Identifiers

NCT02698384

A-54-52030-315

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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