Status:
COMPLETED
A Trial to Assess the Long-term 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 long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Pat...
Eligibility Criteria
Inclusion
- Male or female patients, ≥18 years at screening
- Able to provide written informed consent to participate in the trial
- 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 and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy
- Adequate liver, pancreatic, renal and bone marrow functions
- Normal ECG
Exclusion
- For Roll-over Patients from NCT04076462:
- Unresolved, drug-related serious adverse event (SAE) from the preceding trial
- Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
- For New Patients:
- 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 within 3 years prior to screening
- Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04125836
Start Date
October 10 2019
End Date
April 24 2025
Last Update
December 22 2025
Active Locations (68)
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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