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

Primary Purpose

Acromegaly

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Octreotide capsules

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring acromegaly, IGF-1, growth hormone, Octreolin, octreotide, somatostatin analog

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cedars-Sinai Medical Center
Campus Charité Mitte
ENDOC Center for Endocrine Tumors
Medizinische Klinik Innenstadt
Max Planck Institute of Psychiatry
Praxis for Endocrimology and Diabetology in Oldenburg
Military Hospital, State Health Center 2nd Department of Internal Medicine
Semmelweiss University
University of Pecs
University of Szeged
Servizio di Endocrinologia A.O. Spedali Civili di Brescia
Dipartimento Clinico Sperimentale di Medicina e Farmacologia
Ospedale Molinette
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Vilnius University Hospital Santariskiu Clinics Center of Endocrinology
Unidad de Investigacion Clinica Cardiometabolica de Occidente
Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery
Centro Medico ABC
Leiden University Medical Centre
Erasmus University Medical Center
Autonomous Public Clinical Hospital No. 5
Department of Endocrinology - Jagiellonian University, Krakow
Clinical Hospital of Medical University in Poznan
Bielanski Hospital
Wroclaw Medical University
Endocrinology Institute C.I.Parhon
County Emergency Hospital, Sf. Spiridon, Department of Endocrinology
Clinic for Endocrinology, Diabetes and Metabolism Diseases, Clinical Center of Serbia
Clinical Center of Vojvodina
University Hospital Bratislava, Hospital of L.Derer
National Institute of Endocrinology and Diabetology
Department of Endocrinology and Diabetes, University Medical Centre
University of Warwick - Medical School
St Bartholomew's Hospital West
The Christie Hospital NHS Trust
Oxford Centre for Diabetes, Endocrinology and Metabolism

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Octreotide capsules

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Percentage of Responders at the End of the Extension Treatment Period

Secondary Outcome Measures

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

Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 < 1.3 times the upper limit of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 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.

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

Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.

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

Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 < 1.3 times the upper level of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 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.

Maintenance of Response During the Extension Treatment Period

Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration < 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.

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

The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported.

Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period

Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis.

Full Information

NCT ID

NCT01412424

First Posted

August 5, 2011

Last Updated

July 14, 2017

Sponsor

Chiasma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01412424

Brief Title

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

Official Title

Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiasma, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

155 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Octreotide capsules

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Octreotide capsules

Other Intervention Name(s)

MYCAPSSA™, Formerly known as Octreolin™

Intervention Description

Octreotide was provided in hard gelatin capsules.

Primary Outcome Measure Information:

Title

Percentage of Responders at the End of the Core Treatment Period

Description

Time Frame

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

Title

Percentage of Responders at the End of the Extension Treatment Period

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Maintenance of Response During the Extension Treatment Period

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shlomo Melmed, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Campus Charité Mitte

City

Berlin

Country

Germany

Facility Name

ENDOC Center for Endocrine Tumors

City

Hamburg

ZIP/Postal Code

20357

Country

Germany

Facility Name

Medizinische Klinik Innenstadt

City

Munich

ZIP/Postal Code

80336

Country

Germany

Facility Name

Max Planck Institute of Psychiatry

City

Munich

ZIP/Postal Code

80804

Country

Germany

Facility Name

Praxis for Endocrimology and Diabetology in Oldenburg

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

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

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Semmelweiss University

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

University of Pecs

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

University of Szeged

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Servizio di Endocrinologia A.O. Spedali Civili di Brescia

City

Brescia

ZIP/Postal Code

25128

Country

Italy

Facility Name

Dipartimento Clinico Sperimentale di Medicina e Farmacologia

City

Messina

ZIP/Postal Code

98125

Country

Italy

Facility Name

Ospedale Molinette

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Vilnius University Hospital Santariskiu Clinics Center of Endocrinology

City

Vilnius

ZIP/Postal Code

8661

Country

Lithuania

Facility Name

Unidad de Investigacion Clinica Cardiometabolica de Occidente

City

Guadalajara Jalisco

ZIP/Postal Code

44150

Country

Mexico

Facility Name

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

City

Mexico City

ZIP/Postal Code

14269

Country

Mexico

Facility Name

Centro Medico ABC

City

Mexico D.F.

ZIP/Postal Code

5300

Country

Mexico

Facility Name

Leiden University Medical Centre

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Erasmus University Medical Center

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Autonomous Public Clinical Hospital No. 5

City

Katowice

ZIP/Postal Code

40- 952

Country

Poland

Facility Name

Department of Endocrinology - Jagiellonian University, Krakow

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Clinical Hospital of Medical University in Poznan

City

Poznan

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Bielanski Hospital

City

Warsaw

ZIP/Postal Code

01 - 809

Country

Poland

Facility Name

Wroclaw Medical University

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Endocrinology Institute C.I.Parhon

City

Bucharest

ZIP/Postal Code

11863

Country

Romania

Facility Name

County Emergency Hospital, Sf. Spiridon, Department of Endocrinology

City

Iasi

ZIP/Postal Code

700111

Country

Romania

Facility Name

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

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Center of Vojvodina

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

University Hospital Bratislava, Hospital of L.Derer

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

National Institute of Endocrinology and Diabetology

City

Ľubochňa

ZIP/Postal Code

034 91

Country

Slovakia

Facility Name

Department of Endocrinology and Diabetes, University Medical Centre

City

Ljubliana

ZIP/Postal Code

1525

Country

Slovenia

Facility Name

University of Warwick - Medical School

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

St Bartholomew's Hospital West

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

Facility Name

The Christie Hospital NHS Trust

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Oxford Centre for Diabetes, Endocrinology and Metabolism

City

Oxford

ZIP/Postal Code

OX37LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34173129

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. Erratum In: Pituitary. 2021 Aug 4;:

Results Reference

derived

PubMed Identifier

25664604

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. Erratum In: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. J Clin Endocrinol Metab. 2020 Dec 1;105(12):

Results Reference

derived

Links:

URL

http://www.chiasmapharma.com

Description

Sponsor website

Learn more about this trial

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

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