Clinical trial NCT03252353: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acromegaly
Keywords: Octreotide Capsules, Acromegaly, OPTIMAL, MYCAPSSA
Lead sponsor: Chiasma, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
timeFrame: Week 36
Secondary outcomes:
measure: Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period
timeFrame: Week 36
measure: Number of Patients Who Begin Rescue Treatment
timeFrame: Week 36
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University Clinical Trials Unit
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Darlinghurst
country: Australia
facility: St Vincent's Private Hospital-NSW
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Public Hospital
state: New South Wales
city: Fitzroy
country: Australia
facility: St Vincent's Hospital-VIC
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Parkville
country: Australia
facility: Melbourne Health
state: Victoria
city: Nedlands
country: Australia
facility: Keogh Institute (Sir Charles Gardner)
state: Western Australia
city: Sofia
country: Bulgaria
facility: University Specialized Hospital for Active Treatment of Endocrinology "Acad. Iv. Pencev" EAD
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: London
country: Canada
facility: St Joseph's Health Care
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet The Department of Endocrinology
city: Aachen
country: Germany
facility: RWTH Aachen University Hospital, Medical Clinic III Division of Endocrinology and Diabetes
city: Munich
country: Germany
facility: Klinikum der LMU Muenchen, Medizinische Klinik und Poliklinik IV, Endokrinologie
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont, II. sz. Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: University of Semmelweiss, Budapest
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, I. Belgyógyászati Klinika
city: Jerusalem
country: Israel
facility: Hadassah Ein-Karem Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Monserrato
country: Italy
facility: Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana, Università di Pisa
city: Riga
country: Latvia
facility: Riga Eastern Clinical University, Hospital Gailezers Department of Endocrinology
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Gdansk
country: Poland
facility: Katedra i Klinika Endokrynologii i Chorob Wewnetrznych
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Okulistyki i Onkologii Samodzielny Publiczny Szpital Kliniczny Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Endokrynologii
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Endokrynologii
city: Warszawa
country: Poland
facility: Klinika Chorob Wewnetrznych i Endokrynologii
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
city: Ljubljana
country: Slovenia
facility: Medical University Centre Ljubljana
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Ankara
country: Turkey
facility: Ankara University, Faculty of Medicine
city: Ankara
country: Turkey
facility: Hacettepe University Medical School
city: İzmir
country: Turkey
facility: Ege University Medical Faculty Internal Diseases
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Pituitary Center at Baylor St. Luke's Medical
name: Susan L Samson, MD PhD
role: STUDY_CHAIR
References:
citation: Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9.
citation: Tuvia S, Atsmon J, Teichman SL, Katz S, Salama P, Pelled D, Landau I, Karmeli I, Bidlingmaier M, Strasburger CJ, Kleinberg DL, Melmed S, Mamluk R. Oral octreotide absorption in human subjects: comparable pharmacokinetics to parenteral octreotide and effective growth hormone suppression. J Clin Endocrinol Metab. 2012 Jul;97(7):2362-9. doi: 10.1210/jc.2012-1179. Epub 2012 Apr 26.
citation: Labadzhyan A, Nachtigall LB, Fleseriu M, Gordon MB, Molitch M, Kennedy L, Samson SL, Greenman Y, Biermasz N, Bolanowski M, Haviv A, Ludlam W, Patou G, Strasburger CJ. Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results. Pituitary. 2021 Dec;24(6):943-953. doi: 10.1007/s11102-021-01163-2. Epub 2021 Jun 25.
citation: Samson SL, Nachtigall LB, Fleseriu M, Gordon MB, Bolanowski M, Labadzhyan A, Ur E, Molitch M, Ludlam WH, Patou G, Haviv A, Biermasz N, Giustina A, Trainer PJ, Strasburger CJ, Kennedy L, Melmed S. Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide. J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3785-97. doi: 10.1210/clinem/dgaa526.