Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly

NCT ID: NCT01412424

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-05-31

Brief Summary

MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety of MYCAPSSA™ treatment in patients with acromegaly.

Detailed Description

The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months. The Core Treatment Period consisted of 2 phases, a Dose Escalation Phase of at least 2 months to identify the therapeutic dose for each study participant and a Fixed Dose Phase of 2 to 5 months during which the therapeutic dose was maintained.

Participants were eligible to enter the Fixed Dose Phase of the Core Treatment Period if they were clinically and biochemically controlled. The same criteria were used to allow entry into the voluntary 6-month Extension Treatment Period.

The Core Treatment Period of the study was completed if the participant had at least 2 months of treatment in the Fixed Dose Phase and a total treatment duration of at least 7 months. Participants who elected to continue into the Extension Treatment Period maintained their therapeutic dose during this period. At the end of the study (after the last dose of MYCAPSSA in either the Core Treatment Period or the Extension Treatment Period), there was a 2-week follow-up period for safety assessments.

Conditions

Acromegaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Octreotide capsules

Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.

Group Type: EXPERIMENTAL

Octreotide capsules

Intervention Type: DRUG

Octreotide was provided in hard gelatin capsules.

Interventions

Octreotide capsules

Octreotide was provided in hard gelatin capsules.

Intervention Type: DRUG

Other Intervention Names

MYCAPSSA™; Formerly known as Octreolin™

Eligibility Criteria

Inclusion Criteria

• Adult subjects, aged 18 to 75 years old, inclusive.
• Subjects with acromegaly defined as documented evidence of growth hormone-secreting pituitary tumor that is abnormally responsive to glucose, or documented elevated insulin-like growth factor-1 (IGF-1), who are currently receiving a stable dose of a somatostatin analog for at least the previous 3 months.
• A serum IGF-1 level < 1.3 x the upper limit of normal (ULN) and a serum growth hormone (GH) level < 2.5 ng/mL.
• Subjects able and willing to comply with the requirements of the protocol.
• Subjects able to swallow capsules.
• Subjects able to understand and sign written informed consent to participate in the study.

Exclusion Criteria

• Receiving regular injections of a somatostatin analog less frequently than once a month, ie, longer than every 4 weeks.
• Symptomatic cholelithiasis.
• Received pituitary radiotherapy within ten years prior to screening.
• Undergone pituitary surgery within the prior 6 months.
• Any condition that may jeopardize study participation.
• Clinically significant gastrointestinal (GI), renal, or hepatic disease as determined by the Investigator.
• Conditions (eg, bariatric surgery) significantly affecting gastric acidity or emptying.
• Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use of H2-antagonists.
• Female patients who are pregnant or lactating.
• Current or recent (< 3 months) therapy with pegvisomant.
• Current or recent (< 2 months) therapy with cabergoline.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiasma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shlomo Melmed, MD

Role: STUDY_CHAIR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Campus Charité Mitte

Berlin, , Germany

ENDOC Center for Endocrine Tumors

Hamburg, , Germany

Medizinische Klinik Innenstadt

Munich, , Germany

Max Planck Institute of Psychiatry

Munich, , Germany

Praxis for Endocrimology and Diabetology in Oldenburg

Oldenburg, , Germany

Military Hospital, State Health Center 2nd Department of Internal Medicine

Budapest, , Hungary

Semmelweiss University

Budapest, , Hungary

University of Pecs

Pécs, , Hungary

University of Szeged

Szeged, , Hungary

Servizio di Endocrinologia A.O. Spedali Civili di Brescia

Brescia, , Italy

Dipartimento Clinico Sperimentale di Medicina e Farmacologia

Messina, , Italy

Ospedale Molinette

Torino, , Italy

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, , Lithuania

Vilnius University Hospital Santariskiu Clinics Center of Endocrinology

Vilnius, , Lithuania

Unidad de Investigacion Clinica Cardiometabolica de Occidente

Guadalajara Jalisco, , Mexico

Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery

Mexico City, , Mexico

Centro Medico ABC

Mexico City, , Mexico

Leiden University Medical Centre

Leiden, , Netherlands

Erasmus University Medical Center

Rotterdam, , Netherlands

Autonomous Public Clinical Hospital No. 5

Katowice, , Poland

Department of Endocrinology - Jagiellonian University, Krakow

Krakow, , Poland

Clinical Hospital of Medical University in Poznan

Poznan, , Poland

Bielanski Hospital

Warsaw, , Poland

Wroclaw Medical University

Wroclaw, , Poland

Endocrinology Institute C.I.Parhon

Bucharest, , Romania

County Emergency Hospital, Sf. Spiridon, Department of Endocrinology

Iași, , Romania

Clinic for Endocrinology, Diabetes and Metabolism Diseases, Clinical Center of Serbia

Belgrade, , Serbia

Clinical Center of Vojvodina

Novi Sad, , Serbia

University Hospital Bratislava, Hospital of L.Derer

Bratislava, , Slovakia

National Institute of Endocrinology and Diabetology

Ľubochňa, , Slovakia

Department of Endocrinology and Diabetes, University Medical Centre

Ljubliana, , Slovenia

University of Warwick - Medical School

Coventry, , United Kingdom

St Bartholomew's Hospital West

London, , United Kingdom

The Christie Hospital NHS Trust

Manchester, , United Kingdom

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, , United Kingdom

Countries

United States; Germany; Hungary; Italy; Lithuania; Mexico; Netherlands; Poland; Romania; Serbia; Slovakia; Slovenia; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34173129 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25664604 (View on PubMed)

Related Links

http://www.chiasmapharma.com

Sponsor website

Other Identifiers

CH-ACM-01

Identifier Type: -

Identifier Source: org_study_id