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Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (OPTIMAL)

Primary Purpose

Acromegaly

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
octreotide capsules
Matching placebo
Sponsored by
Chiasma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Octreotide Capsules, Acromegaly, OPTIMAL, MYCAPSSA

Eligibility Criteria

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

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

Sites / Locations

  • Keck Medical Center of University of Southern California
  • Cedars-Sinai Medical Center
  • UCLA Medical Center
  • Stanford University School of Medicine
  • University of Colorado
  • The Emory Clinic
  • John H. Stroger Jr. Hospital of Cook County
  • Johns Hopkins University Clinical Trials Unit
  • Massachusetts General Hospital
  • Washington University School of Medicine
  • Columbia University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Cleveland Clinic
  • Ohio State University
  • Oregon Health and Science University
  • Thomas Jefferson University Hospital
  • Allegheny Endocrinology Associates
  • Baylor College of Medicine
  • Huntsman Cancer Hospital
  • St Vincent's Private Hospital-NSW
  • Royal North Shore Public Hospital
  • St Vincent's Hospital-VIC
  • The Alfred
  • Melbourne Health
  • Keogh Institute (Sir Charles Gardner)
  • University Specialized Hospital for Active Treatment of Endocrinology "Acad. Iv. Pencev" EAD
  • University of British Columbia
  • St Joseph's Health Care
  • McGill University Health Centre
  • Aarhus University Hospital
  • Rigshospitalet The Department of Endocrinology
  • RWTH Aachen University Hospital, Medical Clinic III Division of Endocrinology and Diabetes
  • Klinikum der LMU Muenchen, Medizinische Klinik und Poliklinik IV, Endokrinologie
  • Magyar Honvedseg Egeszsegugyi Kozpont, II. sz. Belgyogyaszati Osztaly
  • University of Semmelweiss, Budapest
  • Szegedi Tudományegyetem, I. Belgyógyászati Klinika
  • Hadassah Ein-Karem Medical Center
  • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
  • Azienda Ospedaliero-Universitaria Pisana, Università di Pisa
  • Riga Eastern Clinical University, Hospital Gailezers Department of Endocrinology
  • Leids Universitair Medisch Centrum
  • Erasmus Medisch Centrum
  • Dunedin Hospital
  • Wellington Hospital
  • Katedra i Klinika Endokrynologii i Chorob Wewnetrznych
  • Uniwersyteckie Centrum Okulistyki i Onkologii Samodzielny Publiczny Szpital Kliniczny Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Endokrynologii
  • Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Endokrynologii
  • Klinika Chorob Wewnetrznych i Endokrynologii
  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
  • Medical University Centre Ljubljana
  • Sahlgrenska University Hospital
  • Ankara University, Faculty of Medicine
  • Hacettepe University Medical School
  • Ege University Medical Faculty Internal Diseases
  • Erciyes University Medical Faculty
  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
  • Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
  • Royal Victoria Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Octreotide capsules

Matching Placebo

Arm Description

Octreotide capsules

Matching placebo capsules

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of Patients Who Begin Rescue Treatment
Number of Patients who Began Rescue Treatment Prior to and Including Week 36

Full Information

First Posted
August 10, 2017
Last Updated
November 4, 2020
Sponsor
Chiasma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03252353
Brief Title
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Acronym
OPTIMAL
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 13, 2019 (Actual)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiasma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Octreotide Capsules, Acromegaly, OPTIMAL, MYCAPSSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Octreotide capsules
Arm Type
Active Comparator
Arm Description
Octreotide capsules
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules
Intervention Type
Drug
Intervention Name(s)
octreotide capsules
Other Intervention Name(s)
MYCAPSSA
Intervention Description
octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Other Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules
Primary Outcome Measure Information:
Title
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
Description
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.
Time Frame
Week 36
Secondary Outcome Measure Information:
Title
Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period
Description
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.
Time Frame
Week 36
Title
Number of Patients Who Begin Rescue Treatment
Description
Number of Patients who Began Rescue Treatment Prior to and Including Week 36
Time Frame
Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Samson, MD PhD
Organizational Affiliation
Pituitary Center at Baylor St. Luke's Medical
Official's Role
Study Chair
Facility Information:
Facility Name
Keck Medical Center of University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
John H. Stroger Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins University Clinical Trials Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Endocrinology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
St Vincent's Private Hospital-NSW
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal North Shore Public Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
St Vincent's Hospital-VIC
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Melbourne Health
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Keogh Institute (Sir Charles Gardner)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
University Specialized Hospital for Active Treatment of Endocrinology "Acad. Iv. Pencev" EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Rigshospitalet The Department of Endocrinology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
RWTH Aachen University Hospital, Medical Clinic III Division of Endocrinology and Diabetes
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum der LMU Muenchen, Medizinische Klinik und Poliklinik IV, Endokrinologie
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont, II. sz. Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
H-1062
Country
Hungary
Facility Name
University of Semmelweiss, Budapest
City
Budapest
ZIP/Postal Code
H-1088
Country
Hungary
Facility Name
Szegedi Tudományegyetem, I. Belgyógyászati Klinika
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Hadassah Ein-Karem Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
City
Monserrato
ZIP/Postal Code
09042
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana, Università di Pisa
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Riga Eastern Clinical University, Hospital Gailezers Department of Endocrinology
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Katedra i Klinika Endokrynologii i Chorob Wewnetrznych
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Uniwersyteckie Centrum Okulistyki i Onkologii Samodzielny Publiczny Szpital Kliniczny Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Endokrynologii
City
Katowice
ZIP/Postal Code
40-541
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Endokrynologii
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Klinika Chorob Wewnetrznych i Endokrynologii
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Medical University Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Ankara University, Faculty of Medicine
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Hacettepe University Medical School
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Ege University Medical Faculty Internal Diseases
City
İzmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Erciyes University Medical Faculty
City
Kayseri
ZIP/Postal Code
38080
Country
Turkey
Facility Name
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
background
PubMed Identifier
22539587
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.
Results Reference
background
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
32882036
Citation
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.
Results Reference
derived
Links:
URL
http://www.chiasmapharma.com/
Description
Chiasma Web Page
URL
https://www.ncbi.nlm.nih.gov/pubmed/25664604
Description
Melmed et al. JCEM 2015

Learn more about this trial

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

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