A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Phase 3

Completed

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

• Registration Number: NCT04076462
• Lead Sponsor: Camurus AB

Brief Summary

The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-19
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-02
• Status Verified: 2024-04
• Disposition First Submitted: 2024-04-24
• Last Update Submitted: 2024-04-24
• Disposition First Posted: 2024-04-25
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Male or female patients, ≥18 years at screening
• 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

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Exclusion Criteria

• GH ≥2.5 μg/L at screening (cycle)
• 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%)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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, six months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
Matching placebo	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with mean IGF-1 levels ≤1xULN	Week 22 and 24

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with mean GH levels <2.5 µg/L	Week 24
Proportion of patients/partners declared competent by a healthcare professional to administer intervention	Week 0 to 20 and week 24	During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place
Proportion of patients with mean IGF-1 levels ≤1xULN, including patients with dose reduction	Week 22 and 24
Incidence of treatment emergent adverse events	Week 0 to 24
Proportion of patients with mean IGF-1 levels ≤1xULN at Week 22/Week 24 and mean GH levels <2.5 µg/L at Week 24	Week 22 and 24
Proportion of patients with mean GH levels <1.0 µg/L	Week 24
Octreotide plasma concentrations over time	Week 0 to 24

Trial Locations

Locations (62)

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

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University in St. Louis, School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Medicover Neuroendokrinologie; 🇩🇪 Munich, Germany

LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV; 🇩🇪 Munich, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin; 🇩🇪 Frankfurt, Germany

General Hospital of Athens "Laiko", Endocrinology University Clinic; 🇬🇷 Athens, Greece

Medicover Oldenburg MVZ; 🇩🇪 Oldenburg, Germany

Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism; 🇬🇷 Athens, Greece

Military Healt Center, 2nd Department of Internal Medicine; 🇭🇺 Budapest, Hungary

IRCCS Policlinico San Martino; 🇮🇹 Genova, Italy

SZTE ÁOK I.sz. Belgyógyászati Klinika; 🇭🇺 Szeged, Hungary

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

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

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

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

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

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

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

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

Saratov Regional Clinic Hospital; 🇷🇺 Saratov, Russian Federation

University Hospital of Alicante; 🇪🇸 Alicante, Spain

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

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

University Hospital Complex A Coruña; 🇪🇸 Coruña, Spain

University Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

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

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

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

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

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

Eskisehir Osmangazi University Medical Faculty; 🇹🇷 Eskişehir, Turkey

Karadeniz Technical University Farabi Hospital; 🇹🇷 Trabzon, 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

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

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

Salford Royal Foundation Trust; 🇬🇧 Salford, United Kingdom

General Hospital of Thessaloniki "Ippokratio"; 🇬🇷 Thessaloníki, Greece

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

College of Medical and Dental Sciences; 🇬🇧 Birmingham, United Kingdom

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

Prufen Clinical Research LLC; 🇺🇸 Miami, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

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

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Allegheny Endocrinology Associates; 🇺🇸 Pittsburgh, Pennsylvania, United States

Research Institute of Dallas; 🇺🇸 Dallas, Texas, United States

Hospital Universitario de la Ribera; 🇪🇸 Valencia, Spain

University Hospitals Coventry and Warwickshire NHS Trust; 🇬🇧 Coventry, United Kingdom

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States