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

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04125836
• Other study ID #: HS-19-647
• Secondary ID: 2019-002190-66
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 10, 2019
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: Camurus AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients

Locations

Country	Name	City	State
Germany	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
Greece	Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism	Athens
Greece	General Hospital of Athens "Laiko", Endocrinology University Clinic	Athens
Greece	General Hospital of Thessaloniki "Ippokratio"	Thessaloníki
Hungary	Military Health Center, 2nd Department of Internal Medicine	Budapest
Hungary	SZTE ÁOK I.sz. Belgyógyászati Klinika	Szeged
Italy	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
Poland	Centrum Nowoczesnych Terapii "Dobry Lekarz"	Kraków
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie	Kraków
Poland	Amicare Sp. z o.o. Sp. K.	Lódz
Poland	Piekarskie Centrum Medyczne, Szpital Miejski	Piekary Slaskie
Russian Federation	Interregional Clinical Diagnostic Center	Kazan
Russian Federation	"Atlas" Medical Center	Moscow
Russian Federation	Sechenov Moscow First State Medical University	Moscow
Russian Federation	Vladimirsky Moscow Regional Research Clinical Institute	Moscow
Russian Federation	Novosibirsk State Regional Clinical Hospital	Novosibirsk
Russian Federation	Interregional Clinical Diagnostic Center	Ryazan'
Russian Federation	Saratov Regional Clinic Hospital	Saratov
Serbia	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
Spain	University Hospital of Alicante	Alicante
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	University Hospital Complex A Coruña	Coruña
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Princesa	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 de la Ribera	Valencia
Spain	Hospital Universitario y Politécnico La Fé	Valencia
Turkey	Akdeniz University Faculty of Medicine Department of Endocrinology	Antalya
Turkey	Aydin Adnan Menderes University Research and Application Hospital	Aydin
Turkey	Pamukkale University Faculty of Medicine Department of Endocrinology	Denizli
Turkey	Eskisehir Osmangazi University Medical Faculty	Eskisehir
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
United Kingdom	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 States	University of Michigan	Ann Arbor	Michigan
United States	University of Cincinnati	Cincinnati	Ohio
United States	Research Institute of Dallas	Dallas	Texas
United States	Palm Research Center	Las Vegas	Nevada
United States	UCLA Department of Medicine Division of Endocrinology	Los Angeles	California
United States	Prufen Clinical Research LLC	Miami	Florida
United States	Columbia University Medical Center	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University in St. Louis, School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Camurus AB

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Hungary,  Italy,  Poland,  Russian Federation,  Serbia,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of adverse events (AEs)		Week 0-52
Secondary	Proportion of patients with mean IGF-1 levels =1xULN and <1.3xULN		Week 50 to 52
Secondary	Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L		Week 50 to 52
Secondary	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
Secondary	Octreotide plasma concentrations over time		Week 0-52