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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acromegaly
• Intervention / Treatment: Drug: CAM2029 (octreotide subcutaneous depot)

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Camurus AB; Phone Number: +46462865730; Email: medicalinfo@camurus.com

Study Locations

• Germany
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
  • Freiburg, Germany, 79601
    • Universitätsklinikum Freiburg
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig
  • Munich, Germany, 80336
    • LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
  • Munich, Germany, 81667
    • Medicover Neuroendokrinologie
  • Oldenburg, Germany, 26122
    • Medicover Oldenburg MVZ
• Greece
  • Athens, Greece, 115 27
    • General Hospital of Athens "Laiko", Endocrinology University Clinic
  • Athens, Greece, 115 28
    • Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
  • Thessaloníki, Greece, 546 42
    • General Hospital of Thessaloniki "Ippokratio"
• Hungary
  • Budapest, Hungary, 1062
    • Military Health Center, 2nd Department of Internal Medicine
  • Szeged, Hungary, 6720
    • SZTE ÁOK I.sz. Belgyógyászati Klinika
• Italy
  • Genova, Italy, 16132
    • IRCCS Policlinico San Martino
  • Napoli, Italy, 80131
    • Azienda Universitaria "Federico II"
  • Padova, Italy, 35128
    • Azienda Ospedaliera Padova, Department of Internal medicine
  • Roma, Italy
    • Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
  • Verona, Italy, 37134
    • AOUI Verona, Policlinic of GB Rossi
• Poland
  • Kraków, Poland, 30-688
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
  • Kraków, Poland, 31-011
    • Centrum Nowoczesnych Terapii "Dobry Lekarz"
  • Piekary Śląskie, Poland, 41-940
    • Piekarskie Centrum Medyczne, Szpital Miejski
  • Łódź, Poland, 90-644
    • Amicare Sp. z o.o. Sp. K.
• Russian Federation
  • Kazan, Russian Federation, 420087
    • Interregional Clinical Diagnostic Center
  • Moscow, Russian Federation
    • "Atlas" Medical Center
  • Moscow, Russian Federation
    • Sechenov Moscow First State Medical University
  • Moscow, Russian Federation
    • Vladimirsky Moscow Regional Research Clinical Institute
  • Novosibirsk, Russian Federation, 630087
    • Novosibirsk State Regional Clinical Hospital
  • Ryazan', Russian Federation, 420087
    • Interregional Clinical Diagnostic Center
  • Saratov, Russian Federation, 410053
    • Saratov Regional Clinic Hospital
• Serbia
  • Belgrad, Serbia, 11000
    • Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases
• Spain
  • Alicante, Spain, 03010
    • University Hospital of Alicante
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clínic Barcelona
  • Coruña, Spain, 15006 A
    • University Hospital Complex A Coruña
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28009
    • Hospital Universitario Gregorio Marañón
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario Santiago de Compostela
  • Sevilla, Spain, 41013
    • University Hospital Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Valencia, Spain, 46600
    • Hospital Universitario de La Ribera
• Turkey
  • Antalya, Turkey, 07985
    • Akdeniz University Faculty of Medicine Department of Endocrinology
  • Aydın, Turkey, 09010
    • Aydın Adnan Menderes University Research and Application Hospital
  • Denizli, Turkey, 20070
    • Pamukkale University Faculty of Medicine Department of Endocrinology
  • Eskişehir, Turkey, 26480
    • Eskisehir Osmangazi University Medical Faculty
  • Fatih, Turkey, 34098
    • Istanbul University Medical Faculty
  • Kocaeli, Turkey, 41000
    • Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
  • Malatya, Turkey, 44000
    • Inonu University Medical Faculty Endocrinology Department
  • Melikgazi, Turkey, 38039
    • Erciyes University Medical Faculty, Dept. of Endocrinology
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University Farabi Hospital
  • Zonguldak, Turkey, 67600
    • Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
• United Kingdom
  • Birmingham, United Kingdom, B15 2TT
    • College of Medical and Dental Sciences
  • Coventry, United Kingdom, CV2 2DX
    • University Hospitals Coventry and Warwickshire NHS Trust
  • Leeds, United Kingdom, LS97TF
    • Leeds Teaching Hospitals NHS Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Department of Medicine Division of Endocrinology
    • Palo Alto, California, United States, 94305
      • Stanford University Medical Center
  • Florida
    • Miami, Florida, United States, 33130
      • Prufen Clinical Research LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis, School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center
  • New York
    • New York, New York, United States, 10018
      • Columbia University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Endocrinology Associates
  • Texas
    • Dallas, Texas, United States, 75231
      • Research Institute of Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: CAM2029 (octreotide subcutaneous depot); Octreotide subcutaneous depot for monthly injections in acromegaly patients; Other Names: CAM2029

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterization of adverse events (AEs)	Week 0-52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place	Week 0-52
Octreotide plasma concentrations over time		Week 0-52
Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN		Week 50 to 52

Collaborators and Investigators

• Sponsor: Camurus AB
• Investigators: Principal Investigator: Diego Ferone, M.D, University of Genova Endocrinology Unit

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Acromegaly; octreotide; phase 3; CAM2029
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: HS-19-647; 2019-002190-66 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No