Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (OPTIMAL)

November 4, 2020 updated by: Chiasma, Inc.

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Private Hospital-NSW
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Public Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital-VIC
      • Melbourne, Victoria, Australia, 3004
        • The Alfred
      • Parkville, Victoria, Australia, 3050
        • Melbourne Health
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Keogh Institute (Sir Charles Gardner)
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • University Specialized Hospital for Active Treatment of Endocrinology "Acad. Iv. Pencev" EAD
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • University of British Columbia
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St Joseph's Health Care
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet The Department of Endocrinology
  • Germany
      • Aachen, Germany, 52074
        • RWTH Aachen University Hospital, Medical Clinic III Division of Endocrinology and Diabetes
      • Munich, Germany, 80336
        • Klinikum der LMU Muenchen, Medizinische Klinik und Poliklinik IV, Endokrinologie
  • Hungary
      • Budapest, Hungary, H-1062
        • Magyar Honvedseg Egeszsegugyi Kozpont, II. sz. Belgyogyaszati Osztaly
      • Budapest, Hungary, H-1088
        • University of Semmelweiss, Budapest
      • Szeged, Hungary, H-6720
        • Szegedi Tudományegyetem, I. Belgyógyászati Klinika
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Ein-Karem Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center, Beilinson Hospital
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Monserrato, Italy, 09042
        • Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
      • Pisa, Italy, 56124
        • Azienda Ospedaliero-Universitaria Pisana, Università di Pisa
  • Latvia
      • Riga, Latvia, 1038
        • Riga Eastern Clinical University, Hospital Gailezers Department of Endocrinology
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medisch Centrum
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Wellington, New Zealand, 6021
        • Wellington Hospital
  • Poland
      • Gdansk, Poland, 80-211
        • Katedra i Klinika Endokrynologii i Chorob Wewnetrznych
      • Katowice, Poland, 40-541
        • Uniwersyteckie Centrum Okulistyki i Onkologii Samodzielny Publiczny Szpital Kliniczny Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Endokrynologii
      • Krakow, Poland, 31-501
        • Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Endokrynologii
      • Warszawa, Poland, 02-097
        • Klinika Chorob Wewnetrznych i Endokrynologii
      • Wroclaw, Poland, 50-367
        • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Medical University Centre Ljubljana
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • Sahlgrenska University Hospital
  • Turkey
      • Ankara, Turkey, 6100
        • Ankara University, Faculty of Medicine
      • Ankara, Turkey, 6100
        • Hacettepe University Medical School
      • Kayseri, Turkey, 38080
        • Erciyes University Medical Faculty
      • İzmir, Turkey, 35040
        • Ege University Medical Faculty Internal Diseases
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of University of Southern California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger Jr. Hospital of Cook County
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University Clinical Trials Unit
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43203
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Endocrinology Associates
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Huntsman Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Octreotide capsules
Drug: octreotide capsules
octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
Other Names:
  • MYCAPSSA
Placebo Comparator: Matching Placebo
Matching placebo capsules
Drug: Matching placebo
Matching placebo capsules
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
Time Frame: 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.
Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period
Time Frame: 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.
Week 36
Number of Patients Who Begin Rescue Treatment
Time Frame: Week 36
Number of Patients who Began Rescue Treatment Prior to and Including Week 36
Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiasma, Inc.

Investigators

  • Study Chair: Susan L Samson, MD PhD, Pituitary Center at Baylor St. Luke's Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

June 13, 2019

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OOC-ACM-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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