Brief Title
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
Secondary Outcome
Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period
Condition
Acromegaly
Intervention
octreotide capsules
Study Arms / Comparison Groups
Octreotide capsules
Description: Octreotide capsules
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
56
Start Date
September 1, 2017
Completion Date
May 2022
Primary Completion Date
June 13, 2019
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Susan L Samson, MD PhD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03252353
Organization ID
OOC-ACM-303
Responsible Party
Sponsor
Study Sponsor
Chiasma, Inc.
Study Sponsor
Susan L Samson, MD PhD, Study Chair, Pituitary Center at Baylor St. Luke's Medical
Verification Date
November 2020