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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03252353
Other study ID # OOC-ACM-303
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 1, 2017
Est. completion date May 2022

Study information

Verified date November 2020
Source Chiasma, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Active, not recruiting
Enrollment 56
Est. completion date May 2022
Est. primary completion date June 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
octreotide capsules
octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
Matching placebo
Matching placebo capsules

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Chiasma, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Denmark,  Germany,  Hungary,  Israel,  Italy,  Latvia,  Netherlands,  New Zealand,  Poland,  Slovenia,  Sweden,  Turkey,  United Kingdom, 

References & Publications (2)

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. Erratum in: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. 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 Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period 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
Secondary Number of Patients Who Begin Rescue Treatment Number of Patients who Began Rescue Treatment Prior to and Including Week 36 Week 36
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