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

NCT01412424 | Completed Phase 3 Results DMC

• 1 other identifier: CH-ACM-01
• Study Type: interventional
• Target: 155
• Locations: 12 countries
• Sites: 35

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.

Conditions

Acromegaly

Keywords

acromegaly; IGF-1; growth hormone; Octreolin; octreotide; somatostatin analog

Outcome Measures

Primary Outcomes (2)

• Percentage of Responders at the End of the Core Treatment Period

  A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration \< 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.

  End of the core treatment period (up to 7 months)

• Percentage of Responders at the End of the Extension Treatment Period

  A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration \< 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.

  End of the extension treatment period (up to 13 months)

Secondary Outcomes (6)

• Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period

  Baseline and the end of the core treatment period (up to 7 months)

• Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period

  Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)

• Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period

  Beginning and the end of the extension treatment period (up to 6 months)

• Maintenance of Response During the Extension Treatment Period

  Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)

• Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period

  Baseline and the end of the extension treatment period (up to 13 months)

Study Arms (1)

Octreotide capsules

EXPERIMENTAL

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.

Drug: Octreotide capsules

Interventions

Octreotide capsules DRUG

Octreotide was provided in hard gelatin capsules.

Also known as: MYCAPSSA™, Formerly known as Octreolin™

Octreotide capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiasma, Inc.: lead

Study Sites (36)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Campus Charité Mitte

Berlin, Germany

Location

ENDOC Center for Endocrine Tumors

Hamburg, 20357, Germany

Location

Medizinische Klinik Innenstadt

Munich, 80336, Germany

Location

Max Planck Institute of Psychiatry

Munich, 80804, Germany

Location

Praxis for Endocrimology and Diabetology in Oldenburg

Oldenburg, 26122, Germany

Location

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

Budapest, 1062, Hungary

Location

Semmelweiss University

Budapest, 1088, Hungary

Location

University of Pecs

Pécs, 7624, Hungary

Location

University of Szeged

Szeged, 6720, Hungary

Location

Servizio di Endocrinologia A.O. Spedali Civili di Brescia

Brescia, 25128, Italy

Location

Dipartimento Clinico Sperimentale di Medicina e Farmacologia

Messina, 98125, Italy

Location

Ospedale Molinette

Torino, 10126, Italy

Location

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50009, Lithuania

Location

Vilnius University Hospital Santariskiu Clinics Center of Endocrinology

Vilnius, 8661, Lithuania

Location

Unidad de Investigacion Clinica Cardiometabolica de Occidente

Guadalajara Jalisco, 44150, Mexico

Location

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

Mexico City, 14269, Mexico

Location

Centro Medico ABC

Mexico City, 5300, Mexico

Location

Leiden University Medical Centre

Leiden, 2333 ZA, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Autonomous Public Clinical Hospital No. 5

Katowice, 40- 952, Poland

Location

Department of Endocrinology - Jagiellonian University, Krakow

Krakow, 31-501, Poland

Location

Clinical Hospital of Medical University in Poznan

Poznan, 60-355, Poland

Location

Bielanski Hospital

Warsaw, 01 - 809, Poland

Location

Wroclaw Medical University

Wroclaw, 50-367, Poland

Location

Endocrinology Institute C.I.Parhon

Bucharest, 11863, Romania

Location

County Emergency Hospital, Sf. Spiridon, Department of Endocrinology

Iași, 700111, Romania

Location

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

Belgrade, 11000, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

Location

University Hospital Bratislava, Hospital of L.Derer

Bratislava, 833 05, Slovakia

Location

National Institute of Endocrinology and Diabetology

Ľubochňa, 034 91, Slovakia

Location

Department of Endocrinology and Diabetes, University Medical Centre

Ljubliana, 1525, Slovenia

Location

University of Warwick - Medical School

Coventry, CV2 2DX, United Kingdom

Location

St Bartholomew's Hospital West

London, EC1M 6BQ, United Kingdom

Location

The Christie Hospital NHS Trust

Manchester, M13 9WL, United Kingdom

Location

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, OX37LJ, United Kingdom

Location

Related Publications (2)

• 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

• 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 DERIVED

Related Links

• Sponsor website

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: Shlomo Melmed, MD
• Organization: Cedars-Sinai Medical Center

melmed@csmc.edu

310 423-4691

Study Officials

• Shlomo Melmed, MD

  Cedars-Sinai Medical Center

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 9, 2011
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 17, 2017
• Results First Posted: December 1, 2015

Record last verified: 2017-07

Locations

US (1); LI (2); NL (2); HU (4); IT (3); DE (5); PL (5); SE (2); SL (2); GB (4); RO (2); ME (3)