Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

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 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

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