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A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
About
Brief Summary
The purpose of this trial is to assess the long-term safety of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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 prior pituitary radiotherapy
- Adequate liver, pancreatic, renal and bone marrow functions
- Normal ECG
Exclusion Criteria:
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%)
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Study Stats
Protocol No.
19-001807
Category
Endocrinology
Principal Investigator
Location
- UCLA Westwood