Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

• Status: Unknown status
• Trial end date: 2021-02-01
• 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 sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref).

The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.

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

Details

• Lead Sponsor: Chiasma, Inc.
• Treatments: Angiopeptin; Cabergoline; Lanreotide; Octreotide; Somatostatin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of acromegaly

• Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months

• Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL)

Exclusion Criteria:

• Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks.

• Pituitary radiotherapy within 5 years

• Pituitary surgery within six months

• Patients who previously participated in CH-ACM-01 study

• Any clinically significant uncontrolled concomitant disease

• Symptomatic cholelithiasis

• Previous treatment with:

• Pegvisomant, within 12 weeks

• Dopamine agonists, within 6 weeks

• Pasireotide, within 12 weeks