Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

NCT03252353 | Unknown Phase 3 Results DMC FDA Drug

• 1 other identifier: OOC-ACM-303
• Study Type: interventional
• Target: 56
• Locations: 17 countries
• Sites: 60

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).

Conditions

Acromegaly

Keywords

Octreotide Capsules, Acromegaly, OPTIMAL, MYCAPSSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period

  Week 36

• Number of Patients Who Begin Rescue Treatment

  Week 36

Study Arms (2)

Octreotide capsules

ACTIVE COMPARATOR

Octreotide capsules

Drug: octreotide capsules

Matching Placebo

PLACEBO COMPARATOR

Matching placebo capsules

Drug: Matching placebo

Interventions

octreotide capsules DRUG

octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)

Also known as: MYCAPSSA

Octreotide capsules

Matching placebo DRUG

Matching placebo capsules

Also known as: Placebo

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiasma, Inc.: lead

Study Sites (60)

Keck Medical Center of University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University Clinical Trials Unit

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43203, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Huntsman Cancer Hospital

Salt Lake City, Utah, 84108, United States

Location

St Vincent's Private Hospital-NSW

Darlinghurst, New South Wales, 2010, Australia

Location

Royal North Shore Public Hospital

St Leonards, New South Wales, 2065, Australia

Location

St Vincent's Hospital-VIC

Fitzroy, Victoria, 3065, Australia

Location

The Alfred

Melbourne, Victoria, 3004, Australia

Location

Melbourne Health

Parkville, Victoria, 3050, Australia

Location

Keogh Institute (Sir Charles Gardner)

Nedlands, Western Australia, 6009, Australia

Location

University Specialized Hospital for Active Treatment of Endocrinology "Acad. Iv. Pencev" EAD

Sofia, 1431, Bulgaria

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Rigshospitalet The Department of Endocrinology

Copenhagen, 2100, Denmark

Location

RWTH Aachen University Hospital, Medical Clinic III Division of Endocrinology and Diabetes

Aachen, 52074, Germany

Location

Klinikum der LMU Muenchen, Medizinische Klinik und Poliklinik IV, Endokrinologie

Munich, 80336, Germany

Location

Magyar Honvedseg Egeszsegugyi Kozpont, II. sz. Belgyogyaszati Osztaly

Budapest, H-1062, Hungary

Location

University of Semmelweiss, Budapest

Budapest, H-1088, Hungary

Location

Szegedi Tudományegyetem, I. Belgyógyászati Klinika

Szeged, H-6720, Hungary

Location

Hadassah Ein-Karem Medical Center

Jerusalem, 91120, Israel

Location

Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia

Monserrato, 09042, Italy

Location

Azienda Ospedaliero-Universitaria Pisana, Università di Pisa

Pisa, 56124, Italy

Location

Riga Eastern Clinical University, Hospital Gailezers Department of Endocrinology

Riga, 1038, Latvia

Location

Leids Universitair Medisch Centrum

Leiden, 2333 ZA, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Katedra i Klinika Endokrynologii i Chorob Wewnetrznych

Gdansk, 80-211, Poland

Location

Uniwersyteckie Centrum Okulistyki i Onkologii Samodzielny Publiczny Szpital Kliniczny Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Endokrynologii

Katowice, 40-541, Poland

Location

Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Endokrynologii

Krakow, 31-501, Poland

Location

Klinika Chorob Wewnetrznych i Endokrynologii

Warsaw, 02-097, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami

Wroclaw, 50-367, Poland

Location

Medical University Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Sahlgrenska University Hospital

Gothenburg, SE-413 45, Sweden

Location

Ankara University, Faculty of Medicine

Ankara, 6100, Turkey (Türkiye)

Location

Hacettepe University Medical School

Ankara, 6100, Turkey (Türkiye)

Location

Ege University Medical Faculty Internal Diseases

Izmir, 35040, Turkey (Türkiye)

Location

Erciyes University Medical Faculty

Kayseri, 38080, Turkey (Türkiye)

Location

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 25664604 BACKGROUND

• 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.

  PMID: 22539587 BACKGROUND

• 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.

  PMID: 34173129 DERIVED

• 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.

  PMID: 32882036 DERIVED

Related Links

• Chiasma Web Page
• Melmed et al. JCEM 2015

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Asi Haviv, VP Clinical development
• Organization: Chiasma

Asi@chiasmapharma.com

972-8-939-3888

Study Officials

• Susan L Samson, MD PhD

  Pituitary Center at Baylor St. Luke's Medical

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 17, 2017
• Study Start: September 1, 2017
• Primary Completion: June 13, 2019
• Study Completion: May 1, 2022
• Last Updated: November 23, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); CA (3); IL (3); AU (6); DK (2); NZ (2); SL (1); LA (1); HU (3); BU (1); IT (2); TU (4); US (19); SE (1); GB (3); PL (5); DE (2)