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

Phase 3

Active, not recruiting

• Conditions: Acromegaly
• Interventions: Drug: CAM2029 (octreotide subcutaneous depot)

• Registration Number: NCT04125836
• Lead Sponsor: Camurus AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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

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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%)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAM2029 (octreotide subcutaneous depot)	CAM2029 (octreotide subcutaneous depot)	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.

Primary Outcome Measures

Name	Time	Method
Characterization of adverse events (AEs)	Week 0-52

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN	Week 50 to 52
Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L	Week 50 to 52
Proportion of patients/partners declared competent by a healthcare professional to administer intervention	Week 0-52	During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place
Octreotide plasma concentrations over time	Week 0-52

Trial Locations

Locations (67)

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

UCLA Department of Medicine Division of Endocrinology; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Piekarskie Centrum Medyczne, Szpital Miejski; 🇵🇱 Piekary Śląskie, Poland

Centrum Nowoczesnych Terapii "Dobry Lekarz"; 🇵🇱 Kraków, Poland

Amicare Sp. z o.o. Sp. K.; 🇵🇱 Łódź, Poland

Interregional Clinical Diagnostic Center; 🇷🇺 Ryazan', Russian Federation

"Atlas" Medical Center; 🇷🇺 Moscow, Russian Federation

Sechenov Moscow First State Medical University; 🇷🇺 Moscow, Russian Federation

University Hospital of Alicante; 🇪🇸 Alicante, Spain

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; 🇺🇸 Saint Louis, Missouri, United States

Palm Research Center; 🇺🇸 Las Vegas, Nevada, United States

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

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, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, 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"; 🇬🇷 Thessaloníki, Greece

Military Health 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; 🇮🇹 Padova, 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; 🇵🇱 Kraków, Poland

Vladimirsky Moscow Regional Research Clinical Institute; 🇷🇺 Moscow, Russian Federation

Novosibirsk State Regional Clinical Hospital; 🇷🇺 Novosibirsk, Russian Federation

Saratov Regional Clinic Hospital; 🇷🇺 Saratov, Russian Federation

Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases; 🇷🇸 Belgrad, Serbia

Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases; 🇷🇸 Novi Sad, Serbia

University Hospital Complex A Coruña; 🇪🇸 Coruña, Spain

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain

Complejo Hospitalario Universitario Santiago de Compostela; 🇪🇸 Santiago de Compostela, Spain

University Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital Universitario y Politécnico La Fé; 🇪🇸 Valencia, Spain

Hospital Universitario de la Ribera; 🇪🇸 Valencia, Spain

Akdeniz University Faculty of Medicine Department of Endocrinology; 🇹🇷 Antalya, Turkey

Aydın Adnan Menderes University Research and Application Hospital; 🇹🇷 Aydın, Turkey

Pamukkale University Faculty of Medicine Department of Endocrinology; 🇹🇷 Denizli, Turkey

Eskisehir Osmangazi University Medical Faculty; 🇹🇷 Eskişehir, Turkey

Istanbul University Medical Faculty; 🇹🇷 Fatih, Turkey

Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism; 🇹🇷 Kocaeli, Turkey

Inonu University Medical Faculty Endocrinology Department; 🇹🇷 Malatya, Turkey

Erciyes University Medical Faculty, Dept. of Endocrinology; 🇹🇷 Melikgazi, Turkey

Karadeniz Technical University Farabi Hospital; 🇹🇷 Trabzon, Turkey

Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus; 🇹🇷 Zonguldak, Turkey

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