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

NCT04076462

CompletedPhase 3

Sponsor: Camurus AB

Conditions: Acromegaly

Interventions: CAM2029 (octreotide subcutaneous depot), Matching placebo

Countries: United States, Germany, Greece, Hungary, Italy, Poland, Russia, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 long-acting repeatable (LAR) or lanreotide autogel (ATG) for at least 3 months as monotherapy prior to screening
* Insulin-like growth factor-1 (IGF-1) levels ≤1x upper limit of normal (ULN) at screening
* Adequate liver, pancreatic, renal and bone marrow functions
* Normal ECG

Exclusion Criteria:

* Growth hormone (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%)
Locations (63)
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Miami, Florida, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Cincinnati, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Essen, Germany
  • Frankfurt, Germany
  • Freiburg im Breisgau, Germany
  • Munich, Germany
  • Munich, Germany
  • Oldenburg, Germany
  • Athens, Greece
  • Athens, Greece
  • Thessaloniki, Greece
  • Budapest, Hungary
  • Szeged, Hungary
  • Genova, Italy
  • Naples, Italy
  • Padova, Italy
  • Roma, Italy
  • Verona, Italy
  • Krakow, Poland
  • Krakow, Poland
  • + 33 more on CT.gov