Clinical trial NCT04125836: A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
octreotide
CAM2029
phase 3
Lead sponsor: Camurus AB
Sponsor class: INDUSTRY
First posted: 2019-10-14
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%)

Primary outcomes:
measure: Characterization of adverse events (AEs)
timeFrame: Week 0-52
Secondary outcomes:
measure: Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN
timeFrame: Week 50 to 52
measure: Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L
timeFrame: Week 50 to 52
measure: Proportion of patients/partners declared competent by a healthcare professional to administer intervention
timeFrame: Week 0-52
measure: Octreotide plasma concentrations over time
timeFrame: Week 0-52
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Medicine Division of Endocrinology
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Miami
country: United States
facility: Prufen Clinical Research LLC
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis, School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Munich
country: Germany
facility: LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
city: Munich
country: Germany
facility: Medicover Neuroendokrinologie
city: Oldenburg
country: Germany
facility: Medicover Oldenburg MVZ
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko", Endocrinology University Clinic
city: Athens
country: Greece
facility: Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki "Ippokratio"
city: Budapest
country: Hungary
facility: Military Health Center, 2nd Department of Internal Medicine
city: Szeged
country: Hungary
facility: SZTE ÁOK I.sz. Belgyógyászati Klinika
city: Genova
country: Italy
facility: IRCCS Policlinico San Martino
city: Napoli
country: Italy
facility: Azienda Universitaria "Federico II"
city: Padova
country: Italy
facility: Azienda Ospedaliera Padova, Department of Internal medicine
city: Roma
country: Italy
facility: Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
city: Verona
country: Italy
facility: AOUI Verona, Policlinic of GB Rossi
city: Kraków
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
city: Kraków
country: Poland
facility: Centrum Nowoczesnych Terapii "Dobry Lekarz"
city: Piekary Śląskie
country: Poland
facility: Piekarskie Centrum Medyczne, Szpital Miejski
city: Łódź
country: Poland
facility: Amicare Sp. z o.o. Sp. K.
city: Kazan
country: Russian Federation
facility: Interregional Clinical Diagnostic Center
city: Moscow
country: Russian Federation
facility: "Atlas" Medical Center
city: Moscow
country: Russian Federation
facility: Sechenov Moscow First State Medical University
city: Moscow
country: Russian Federation
facility: Vladimirsky Moscow Regional Research Clinical Institute
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital
city: Ryazan'
country: Russian Federation
facility: Interregional Clinical Diagnostic Center
city: Saratov
country: Russian Federation
facility: Saratov Regional Clinic Hospital
city: Belgrad
country: Serbia
facility: Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases
city: Alicante
country: Spain
facility: University Hospital of Alicante
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d&#39;Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Coruña
country: Spain
facility: University Hospital Complex A Coruña
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago de Compostela
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fé
city: Valencia
country: Spain
facility: Hospital Universitario de la Ribera
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Medicine Department of Endocrinology
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University Research and Application Hospital
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Medicine Department of Endocrinology
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty
city: Fatih
country: Turkey
facility: Istanbul University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty Endocrinology Department
city: Melikgazi
country: Turkey
facility: Erciyes University Medical Faculty, Dept. of Endocrinology
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Farabi Hospital
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
city: Birmingham
country: United Kingdom
facility: College of Medical and Dental Sciences
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Royal Foundation Trust
Study officials:
affiliation: University of Genova Endocrinology Unit
name: Diego Ferone, M.D
role: PRINCIPAL_INVESTIGATOR
References: