Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Acromegaly

In brief

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).

Key facts

Study ID

NCT03252353

Run by

Chiasma, Inc.

People needed

56

Starts

2017-09-01

Expected to finish

2022-05-01

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• University of Colorado — Aurora, Colorado, United States
• The Emory Clinic — Atlanta, Georgia, United States
• John H. Stroger Jr. Hospital of Cook County — Chicago, Illinois, United States
• Johns Hopkins University Clinical Trials Unit — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Allegheny Endocrinology Associates — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• St Vincent's Private Hospital-NSW — Darlinghurst, New South Wales, Australia
• Royal North Shore Public Hospital — St Leonards, New South Wales, Australia
• St Vincent's Hospital-VIC — Fitzroy, Victoria, Australia
• The Alfred — Melbourne, Victoria, Australia
• Melbourne Health — Parkville, Victoria, Australia
• Keogh Institute (Sir Charles Gardner) — Nedlands, Western Australia, Australia
• Keck Medical Center of University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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