A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (NCT04125836) | Clinical Trial Compass
CompletedPhase 3
A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
United States135 participantsStarted 2019-10-10
Plain-language 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. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 or without 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 ca…