A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (ACROINNOVA 1)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

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.

Study Overview

• Status: Completed
• Conditions: Acromegaly
• Intervention / Treatment: Drug: CAM2029 (octreotide subcutaneous depot); Drug: Matching placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45147
    • Universitatsklinikum Essen
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
  • Freiburg, Germany, 79601
    • Universitatsklinikum Freiburg
  • 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 Healt 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"
  • Lodz, Poland, 90-644
    • AmiCare Sp. z o.o. Sp. k.
  • Piekary Śląskie, Poland, 41-940
    • Piekarskie Centrum Medyczne, Szpital Miejski
• 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
• Spain
  • Alicante, Spain, 03010
    • University Hospital of Alicante
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Coruña, Spain, 15006 A
    • University Hospital Complex A Coruña
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28009
    • Hospital Universitario Gregorio Maranon
  • 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 Politecnico 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 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

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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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, six months treatment. 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
Placebo Comparator: 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.	Drug: Matching placebo; Matching placebo for CAM2029; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with mean IGF-1 levels ≤1xULN	Week 22 and 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Camurus AB
• Investigators: Principal Investigator: Pamela Freda, M.D, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

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-18-633; 2019-001191-11 (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