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

Sponsor
Camurus AB (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04076462
Collaborator
(none)
78
Enrollment
61
Locations
2
Arms
44.6
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CAM2029 (octreotide subcutaneous depot)
  • Drug: Matching placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 14, 2019
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with mean IGF-1 levels ≤1xULN [Week 22 to 24]

    Secondary Outcome Measures

    1. Proportion of patients with mean GH levels <2.5 µg/L [Week 22 to 24]

    2. Incidence of treatment emergent adverse events and laboratory and ECG abnormalities [At every visit, Week 0 to 24]

    3. 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

    4. Octreotide plasma concentrations over time [At every visit, Week 0 to 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Department of Medicine Division of Endocrinology Los Angeles California United States 90095
    2 Stanford University Medical Center Palo Alto California United States 94305
    3 University of Michigan Ann Arbor Michigan United States 48106
    4 Mayo Clinic Rochester Minnesota United States 55905
    5 Washington University in St. Louis, School of Medicine Saint Louis Missouri United States 63110
    6 Palm Research Center Las Vegas Nevada United States 89148
    7 Columbia University Medical Center New York New York United States 10018
    8 University of Cincinnati Cincinnati Ohio United States 45267
    9 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    10 Allegheny Endocrinology Associates Pittsburgh Pennsylvania United States 15212
    11 Research Institute of Dallas Dallas Texas United States 75231
    12 Universitätsklinikum Essen Essen Germany 45147
    13 Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin Frankfurt Germany 60590
    14 Universitätsklinikum Freiburg Freiburg Germany 79601
    15 LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV Munich Germany 80336
    16 Medicover Neuroendokrinologie Munich Germany 81667
    17 Medicover Oldenburg MVZ Oldenburg Germany 26122
    18 General Hospital of Athens "Laiko", Endocrinology University Clinic Athens Greece 115 27
    19 Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism Athens Greece 115 28
    20 General Hospital of Thessaloniki "Ippokratio" Thessaloníki Greece 546 42
    21 Military Healt Center, 2nd Department of Internal Medicine Budapest Hungary 1062
    22 SZTE ÁOK I.sz. Belgyógyászati Klinika Szeged Hungary 6720
    23 IRCCS Policlinico San Martino Genova Italy 16132
    24 Azienda Universitaria "Federico II" Napoli Italy 80131
    25 Azienda Ospedaliera Padova, Department of Internal medicine Padova Italy 35128
    26 Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology Roma Italy
    27 AOUI Verona, Policlinic of GB Rossi Verona Italy 37134
    28 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Kraków Poland 30-688
    29 Centrum Nowoczesnych Terapii "Dobry Lekarz" Kraków Poland 31-011
    30 Amicare Sp. z o.o. Sp. K. Lodz Poland 90-644
    31 Piekarskie Centrum Medyczne, Szpital Miejski Piekary Śląskie Poland 41-940
    32 Interregional Clinical Diagnostic Center Kazan Russian Federation 420087
    33 "Atlas" Medical Center Moscow Russian Federation
    34 Sechenov Moscow First State Medical University Moscow Russian Federation
    35 Vladimirsky Moscow Regional Research Clinical Institute Moscow Russian Federation
    36 Novosibirsk State Regional Clinical Hospital Novosibirsk Russian Federation 630087
    37 Interregional Clinical Diagnostic Center Ryazan' Russian Federation 420087
    38 Saratov Regional Clinic Hospital Saratov Russian Federation 410053
    39 University Hospital of Alicante Alicante Spain 03010
    40 Hospital Universitario Vall d'Hebron Barcelona Spain 08035
    41 University Hospital Complex A Coruña Coruña Spain 15006 A
    42 Hospital Universitario La Princesa Madrid Spain 28006
    43 Hospital Universitario Gregorio Marañón Madrid Spain 28009
    44 Complejo Hospitalario Universitario Santiago de Compostela Santiago de Compostela Spain 15706
    45 University Hospital Virgen del Rocio Sevilla Spain 41013
    46 Hospital Universitario y Politécnico La Fe Valencia Spain 46026
    47 Hospital Universitario de la Ribera Valencia Spain 46600
    48 Akdeniz University Faculty of Medicine Department of Endocrinology Antalya Turkey 07985
    49 Aydın Adnan Menderes University Research and Application Hospital Aydın Turkey 09010
    50 Pamukkale University Faculty of Medicine Department of Endocrinology Denizli Turkey 20070
    51 Eskisehir Osmangazi University Medical Faculty Eskişehir Turkey 26480
    52 Istanbul University Medical Faculty Fatih Turkey 34098
    53 Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism Kocaeli Turkey 41000
    54 Inonu University Medical Faculty Endocrinology Department Malatya Turkey 44000
    55 Erciyes University Medical Faculty, Dept. of Endocrinology Melikgazi Turkey 38039
    56 Karadeniz Technical University Farabi Hospital Trabzon Turkey 61080
    57 Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus Zonguldak Turkey 67600
    58 University Hospitals Coventry and Warwickshire NHS Trust Coventry United Kingdom CV2 2DX
    59 Leeds Teaching Hospitals NHS Trust Leeds United Kingdom LS97TF
    60 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX
    61 Salford Royal Foundation Trust Salford United Kingdom M6 8HD

    Sponsors and Collaborators

    • Camurus AB

    Investigators

    • Principal Investigator: Pamela Freda, M.D, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Camurus AB
    ClinicalTrials.gov Identifier:
    NCT04076462
    Other Study ID Numbers:
    • HS-18-633
    • 2019-001191-11
    First Posted:
    Sep 3, 2019
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Camurus AB
    Acromegaly
    octreotide
    CAM2029
    phase 3
    Additional relevant MeSH terms:
    Acromegaly
    Octreotide

    Study Results

    No Results Posted as of Jul 25, 2022