Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
- Registration Number
- NCT03252353
- Lead Sponsor
- Chiasma, Inc.
- 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
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (60)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University Clinical Trials Unit
🇺🇸Baltimore, Maryland, United States
Keck Medical Center of University of Southern California
🇺🇸Los Angeles, California, United States
Ankara University, Faculty of Medicine
🇹🇷Ankara, Turkey
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Endokrynologii
🇵🇱Krakow, Poland
Medical University Centre Ljubljana
🇸🇮Ljubljana, Slovenia
Hacettepe University Medical School
🇹🇷Ankara, Turkey
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
St Vincent's Private Hospital-NSW
🇦🇺Darlinghurst, New South Wales, Australia
Royal North Shore Public Hospital
🇦🇺St Leonards, New South Wales, Australia
Keogh Institute (Sir Charles Gardner)
🇦🇺Nedlands, Western Australia, Australia
Aarhus University Hospital
🇩🇰Aarhus, Denmark
St Joseph's Health Care
🇨🇦London, Ontario, Canada
University of Semmelweiss, Budapest
🇭🇺Budapest, Hungary
Rigshospitalet The Department of Endocrinology
🇩🇰Copenhagen, Denmark
Hadassah Ein-Karem Medical Center
🇮🇱Jerusalem, Israel
Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
🇮🇹Monserrato, Italy
Klinika Chorob Wewnetrznych i Endokrynologii
🇵🇱Warszawa, Poland
Erciyes University Medical Faculty
🇹🇷Kayseri, Turkey
Rabin Medical Center, Beilinson Hospital
🇮🇱Petah Tikva, Israel
Azienda Ospedaliero-Universitaria Pisana, Università di Pisa
🇮🇹Pisa, Italy
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Riga Eastern Clinical University, Hospital Gailezers Department of Endocrinology
🇱🇻Riga, Latvia
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Ege University Medical Faculty Internal Diseases
🇹🇷İzmir, Turkey
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
University Specialized Hospital for Active Treatment of Endocrinology "Acad. Iv. Pencev" EAD
🇧🇬Sofia, Bulgaria
Huntsman Cancer Hospital
🇺🇸Salt Lake City, Utah, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Magyar Honvedseg Egeszsegugyi Kozpont, II. sz. Belgyogyaszati Osztaly
🇭🇺Budapest, Hungary
Szegedi Tudományegyetem, I. Belgyógyászati Klinika
🇭🇺Szeged, Hungary
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
John H. Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Allegheny Endocrinology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
RWTH Aachen University Hospital, Medical Clinic III Division of Endocrinology and Diabetes
🇩🇪Aachen, Germany
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Uniwersyteckie Centrum Okulistyki i Onkologii Samodzielny Publiczny Szpital Kliniczny Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Endokrynologii
🇵🇱Katowice, Poland
Wellington Hospital
🇳🇿Wellington, New Zealand
Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Klinikum der LMU Muenchen, Medizinische Klinik und Poliklinik IV, Endokrinologie
🇩🇪Munich, Germany
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
St Vincent's Hospital-VIC
🇦🇺Fitzroy, Victoria, Australia
Melbourne Health
🇦🇺Parkville, Victoria, Australia
Katedra i Klinika Endokrynologii i Chorob Wewnetrznych
🇵🇱Gdansk, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
🇵🇱Wroclaw, Poland
The Alfred
🇦🇺Melbourne, Victoria, Australia