A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
NCT ID: NCT04076462
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2019-08-19
2023-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CAM2029 (octreotide subcutaneous depot)
CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Matching placebo
Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available.
Matching placebo
Matching placebo for CAM2029
Interventions
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CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Matching placebo
Matching placebo for CAM2029
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed
* 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 at screening
* Adequate liver, pancreatic, renal and bone marrow functions
* Normal ECG
Exclusion Criteria
* 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
* Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)
18 Years
ALL
No
Sponsors
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Camurus AB
INDUSTRY
Responsible Party
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Principal Investigators
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Pamela Freda, M.D
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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UCLA Department of Medicine Division of Endocrinology
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Prufen Clinical Research LLC
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis, School of Medicine
St Louis, Missouri, United States
Palm Research Center
Las Vegas, Nevada, United States
Columbia University Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
Research Institute of Dallas
Dallas, Texas, United States
Universitätsklinikum Essen
Essen, , Germany
Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
Frankfurt, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
Munich, , Germany
Medicover Neuroendokrinologie
Munich, , Germany
Medicover Oldenburg MVZ
Oldenburg, , Germany
General Hospital of Athens "Laiko", Endocrinology University Clinic
Athens, , Greece
Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
Athens, , Greece
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, , Greece
Military Healt Center, 2nd Department of Internal Medicine
Budapest, , Hungary
SZTE ÁOK I.sz. Belgyógyászati Klinika
Szeged, , Hungary
IRCCS Policlinico San Martino
Genova, , Italy
Azienda Universitaria "Federico II"
Napoli, , Italy
Azienda Ospedaliera Padova, Department of Internal medicine
Padua, , Italy
Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
Roma, , Italy
AOUI Verona, Policlinic of GB Rossi
Verona, , Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, , Poland
Amicare Sp. z o.o. Sp. K.
Lodz, , Poland
Piekarskie Centrum Medyczne, Szpital Miejski
Piekary Śląskie, , Poland
Interregional Clinical Diagnostic Center
Kazan', , Russia
"Atlas" Medical Center
Moscow, , Russia
Sechenov Moscow First State Medical University
Moscow, , Russia
Vladimirsky Moscow Regional Research Clinical Institute
Moscow, , Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, , Russia
Interregional Clinical Diagnostic Center
Ryazan, , Russia
Saratov Regional Clinic Hospital
Saratov, , Russia
University Hospital Complex A Coruña
A Coruña, , Spain
University Hospital of Alicante
Alicante, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela, , Spain
University Hospital Virgen del Rocio
Seville, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital Universitario de la Ribera
Valencia, , Spain
Akdeniz University Faculty of Medicine Department of Endocrinology
Antalya, , Turkey (Türkiye)
Aydın Adnan Menderes University Research and Application Hospital
Aydin, , Turkey (Türkiye)
Pamukkale University Faculty of Medicine Department of Endocrinology
Denizli, , Turkey (Türkiye)
Eskisehir Osmangazi University Medical Faculty
Eskişehir, , Turkey (Türkiye)
Istanbul University Medical Faculty
Fatih, , Turkey (Türkiye)
Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
Kocaeli, , Turkey (Türkiye)
Inonu University Medical Faculty Endocrinology Department
Malatya, , Turkey (Türkiye)
Erciyes University Medical Faculty, Dept. of Endocrinology
Melikgazi, , Turkey (Türkiye)
Karadeniz Technical University Farabi Hospital
Trabzon, , Turkey (Türkiye)
Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
Zonguldak, , Turkey (Türkiye)
College of Medical and Dental Sciences
Birmingham, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Salford Royal Foundation Trust
Salford, , United Kingdom
Countries
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References
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Glatard A, Friberg-Hietala S, Keutzer L, Hansson A, Johnsson M, Tiberg F. Population Pharmacokinetic Analysis of an Octreotide Depot (CAM2029) in the Treatment of Acromegaly. Clin Pharmacokinet. 2025 Jul;64(7):1079-1092. doi: 10.1007/s40262-025-01522-3. Epub 2025 May 26.
Ferone D, Freda P, Katznelson L, Gatto F, Kadioglu P, Maffei P, Seufert J, Silverstein JM, Spencer-Segal JL, Isaeva E, Dreval A, Harrie M, Svedberg A, Tiberg F. Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1. J Clin Endocrinol Metab. 2025 May 19;110(6):1729-1739. doi: 10.1210/clinem/dgae707.
Other Identifiers
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2019-001191-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HS-18-633
Identifier Type: -
Identifier Source: org_study_id
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