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A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Primary Purpose

Acromegaly

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CAM2029 (octreotide subcutaneous depot)
Sponsored by
Camurus AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, octreotide, CAM2029, phase 3

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female patients, ≥18 years at screening
  • Able to provide written informed consent to participate in the trial
  • Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
  • Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
  • IGF-1 levels ˃1xULN and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with prior pituitary radiotherapy
  • Adequate liver, pancreatic, renal and bone marrow functions
  • Normal ECG

Exclusion Criteria:

For Roll-over Patients from NCT04076462:

  • Unresolved, drug-related serious adverse event (SAE) from the preceding trial
  • Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation

For New Patients:

  • Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer]
  • Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
  • Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
  • Patients who have undergone pituitary surgery within 6 months prior to screening
  • Patients who have received prior pituitary irradiation within 3 years prior to screening
  • Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)

Sites / Locations

  • UCLA Department of Medicine Division of Endocrinology
  • Stanford University Medical Center
  • Prufen Clinical Research LLC
  • University of Michigan
  • Mayo Clinic
  • Washington University in St. Louis, School of Medicine
  • Palm Research Center
  • Columbia University Medical Center
  • University of Cincinnati
  • Thomas Jefferson University
  • Allegheny Endocrinology Associates
  • Research Institute of Dallas
  • Universitätsklinikum Essen
  • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
  • Universitätsklinikum Freiburg
  • Universitätsklinikum Leipzig
  • LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
  • Medicover Neuroendokrinologie
  • Medicover Oldenburg MVZ
  • General Hospital of Athens "Laiko", Endocrinology University Clinic
  • Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
  • General Hospital of Thessaloniki "Ippokratio"
  • Military Health Center, 2nd Department of Internal Medicine
  • SZTE ÁOK I.sz. Belgyógyászati Klinika
  • IRCCS Policlinico San Martino
  • Azienda Universitaria "Federico II"
  • Azienda Ospedaliera Padova, Department of Internal medicine
  • Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
  • AOUI Verona, Policlinic of GB Rossi
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
  • Centrum Nowoczesnych Terapii "Dobry Lekarz"
  • Piekarskie Centrum Medyczne, Szpital Miejski
  • Amicare Sp. z o.o. Sp. K.
  • Interregional Clinical Diagnostic Center
  • "Atlas" Medical Center
  • Sechenov Moscow First State Medical University
  • Vladimirsky Moscow Regional Research Clinical Institute
  • Novosibirsk State Regional Clinical Hospital
  • Interregional Clinical Diagnostic Center
  • Saratov Regional Clinic Hospital
  • Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases
  • Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases
  • University Hospital of Alicante
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic Barcelona
  • University Hospital Complex A Coruña
  • Hospital Universitario La Princesa
  • Hospital Universitario Gregorio Marañón
  • Hospital Regional Universitario de Málaga
  • Complejo Hospitalario Universitario Santiago de Compostela
  • University Hospital Virgen del Rocio
  • Hospital Universitario y Politécnico La Fé
  • Hospital Universitario de la Ribera
  • Akdeniz University Faculty of Medicine Department of Endocrinology
  • Aydın Adnan Menderes University Research and Application Hospital
  • Pamukkale University Faculty of Medicine Department of Endocrinology
  • Eskisehir Osmangazi University Medical Faculty
  • Istanbul University Medical Faculty
  • Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
  • Inonu University Medical Faculty Endocrinology Department
  • Erciyes University Medical Faculty, Dept. of Endocrinology
  • Karadeniz Technical University Farabi Hospital
  • Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
  • College of Medical and Dental Sciences
  • University Hospitals Coventry and Warwickshire NHS Trust
  • Leeds Teaching Hospitals NHS Trust
  • The Christie NHS Foundation Trust
  • Salford Royal Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAM2029 (octreotide subcutaneous depot)

Arm Description

CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.

Outcomes

Primary Outcome Measures

Characterization of adverse events (AEs)

Secondary Outcome Measures

Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN
Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L
Proportion of patients/partners declared competent by a healthcare professional to administer intervention
During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place
Octreotide plasma concentrations over time

Full Information

First Posted
October 11, 2019
Last Updated
August 29, 2023
Sponsor
Camurus AB
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1. Study Identification

Unique Protocol Identification Number
NCT04125836
Brief Title
A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
Official Title
A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camurus AB

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, octreotide, CAM2029, phase 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAM2029 (octreotide subcutaneous depot)
Arm Type
Experimental
Arm Description
CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
Intervention Type
Drug
Intervention Name(s)
CAM2029 (octreotide subcutaneous depot)
Other Intervention Name(s)
CAM2029
Intervention Description
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Primary Outcome Measure Information:
Title
Characterization of adverse events (AEs)
Time Frame
Week 0-52
Secondary Outcome Measure Information:
Title
Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN
Time Frame
Week 50 to 52
Title
Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L
Time Frame
Week 50 to 52
Title
Proportion of patients/partners declared competent by a healthcare professional to administer intervention
Description
During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place
Time Frame
Week 0-52
Title
Octreotide plasma concentrations over time
Time Frame
Week 0-52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients, ≥18 years at screening Able to provide written informed consent to participate in the trial Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening IGF-1 levels ˃1xULN and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy Adequate liver, pancreatic, renal and bone marrow functions Normal ECG Exclusion Criteria: For Roll-over Patients from NCT04076462: Unresolved, drug-related serious adverse event (SAE) from the preceding trial Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation For New Patients: Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer] Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening Patients who have undergone pituitary surgery within 6 months prior to screening Patients who have received prior pituitary irradiation within 3 years prior to screening Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Ferone, M.D
Organizational Affiliation
University of Genova Endocrinology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Department of Medicine Division of Endocrinology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Prufen Clinical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in St. Louis, School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Thomas Jefferson University
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
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79601
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Medicover Neuroendokrinologie
City
Munich
ZIP/Postal Code
81667
Country
Germany
Facility Name
Medicover Oldenburg MVZ
City
Oldenburg
ZIP/Postal Code
26122
Country
Germany
Facility Name
General Hospital of Athens "Laiko", Endocrinology University Clinic
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
General Hospital of Thessaloniki "Ippokratio"
City
Thessaloníki
ZIP/Postal Code
546 42
Country
Greece
Facility Name
Military Health Center, 2nd Department of Internal Medicine
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
SZTE ÁOK I.sz. Belgyógyászati Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
IRCCS Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Universitaria "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Padova, Department of Internal medicine
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
City
Roma
Country
Italy
Facility Name
AOUI Verona, Policlinic of GB Rossi
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii "Dobry Lekarz"
City
Kraków
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Piekarskie Centrum Medyczne, Szpital Miejski
City
Piekary Śląskie
ZIP/Postal Code
41-940
Country
Poland
Facility Name
Amicare Sp. z o.o. Sp. K.
City
Łódź
ZIP/Postal Code
90-644
Country
Poland
Facility Name
Interregional Clinical Diagnostic Center
City
Kazan
ZIP/Postal Code
420087
Country
Russian Federation
Facility Name
"Atlas" Medical Center
City
Moscow
Country
Russian Federation
Facility Name
Sechenov Moscow First State Medical University
City
Moscow
Country
Russian Federation
Facility Name
Vladimirsky Moscow Regional Research Clinical Institute
City
Moscow
Country
Russian Federation
Facility Name
Novosibirsk State Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Interregional Clinical Diagnostic Center
City
Ryazan'
ZIP/Postal Code
420087
Country
Russian Federation
Facility Name
Saratov Regional Clinic Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
University Hospital of Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
University Hospital Complex A Coruña
City
Coruña
ZIP/Postal Code
15006 A
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Hospitalario Universitario Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
University Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fé
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario de la Ribera
City
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Akdeniz University Faculty of Medicine Department of Endocrinology
City
Antalya
ZIP/Postal Code
07985
Country
Turkey
Facility Name
Aydın Adnan Menderes University Research and Application Hospital
City
Aydın
ZIP/Postal Code
09010
Country
Turkey
Facility Name
Pamukkale University Faculty of Medicine Department of Endocrinology
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Eskisehir Osmangazi University Medical Faculty
City
Eskişehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Istanbul University Medical Faculty
City
Fatih
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
City
Kocaeli
ZIP/Postal Code
41000
Country
Turkey
Facility Name
Inonu University Medical Faculty Endocrinology Department
City
Malatya
ZIP/Postal Code
44000
Country
Turkey
Facility Name
Erciyes University Medical Faculty, Dept. of Endocrinology
City
Melikgazi
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Karadeniz Technical University Farabi Hospital
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
City
Zonguldak
ZIP/Postal Code
67600
Country
Turkey
Facility Name
College of Medical and Dental Sciences
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS97TF
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Salford Royal Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

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