Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Phase 3

Brief 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).

Detailed Description: This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.

This study received agreement from the FDA, under a special protocol assessment.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Octreotide capsules	octreotide capsules	Octreotide capsules
Matching Placebo	Matching placebo	Matching placebo capsules

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.	Week 36	Maintenance of response was defined by using the average IGF-1 level of the last 2 available assessments in the DPC period. If the average IGF-1 is ≤ 1×ULN, a patient was classified as a responder (i.e., maintained their biochemical response). If the average IGF-1 is \> 1×ULN, a patient was classified as a non-responder. Patients who discontinue study medication during the DPC period for any reason was classified as non-responders for the primary analysis, regardless of their IGF-1 values.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period	Week 36	Maintenance of GH response was defined as having mean Growth Hormone (5 measurements 30 minutes apart) \< 2.5 ng/mL at the end of the double blind placebo controlled period, out of those who were responders on Somatostatin Receptor Ligands (SRLs) injections at Screening.
Number of Patients Who Begin Rescue Treatment	Week 36	Number of Patients who Began Rescue Treatment Prior to and Including Week 36

Locations (60): Keck Medical Center of University of Southern California
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Los Angeles, California, United States
Cedars-Sinai Medical Center
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Los Angeles, California, United States
UCLA Medical Center
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Los Angeles, California, United States
Stanford University School of Medicine
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Palo Alto, California, United States
University of Colorado
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Aurora, Colorado, United States
The Emory Clinic
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Atlanta, Georgia, United States
John H. Stroger Jr. Hospital of Cook County
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Chicago, Illinois, United States
Johns Hopkins University Clinical Trials Unit
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Baltimore, Maryland, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Washington University School of Medicine
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Saint Louis, Missouri, United States
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Keck Medical Center of University of Southern California
🇺🇸Los Angeles, California, United States