Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiasma, Inc.
• Treatments: Octreotide

Criteria

Inclusion Criteria:

• Documented evidence of active acromegaly

• Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy

• Biochemically controlled

Exclusion Criteria:

• Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label

• Pituitary surgery within six months

• Conventional or stereotactic pituitary radiotherapy any time in the past

• Patients who previously participated in CH-ACM-01 or OOC-ACM-302

• Any clinically significant uncontrolled concomitant disease

• Symptomatic cholelithiasis

• Pegvisomant, within 24 weeks

• Dopamine agonists, within 12 weeks

• Pasireotide, within 24 weeks