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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT04076462

Run by

Camurus AB

People needed

72

Starts

2019-08-19

Expected to finish

2023-05-02

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%)

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Prufen Clinical Research LLC — Miami, Florida, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University in St. Louis, School of Medicine — St Louis, Missouri, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Columbia University Medical Center — New York, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Allegheny Endocrinology Associates — Pittsburgh, Pennsylvania, United States
• Research Institute of Dallas — Dallas, Texas, United States
• Universitätsklinikum Essen — Essen, Germany
• Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin — Frankfurt, Germany
• Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
• LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV — Munich, Germany
• Medicover Neuroendokrinologie — Munich, Germany
• Medicover Oldenburg MVZ — Oldenburg, Germany
• General Hospital of Athens "Laiko", Endocrinology University Clinic — Athens, Greece
• Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism — Athens, Greece
• General Hospital of Thessaloniki "Ippokratio" — Thessaloniki, Greece
• Military Healt Center, 2nd Department of Internal Medicine — Budapest, Hungary
• SZTE ÁOK I.sz. Belgyógyászati Klinika — Szeged, Hungary
• IRCCS Policlinico San Martino — Genova, Italy
• Azienda Universitaria "Federico II" — Naples, Italy
• UCLA Department of Medicine Division of Endocrinology — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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