Status:
COMPLETED
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
Lead Sponsor:
Camurus AB
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04076462
Start Date
August 19 2019
End Date
May 2 2023
Last Update
April 25 2024
Active Locations (63)
Enter a location and click search to find clinical trials sorted by distance.
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
Prufen Clinical Research LLC
Miami, Florida, United States, 33130
4
University of Michigan
Ann Arbor, Michigan, United States, 48106