A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
Trial ID or NCT#
NCT04125836
Status
RECRUITING
Purpose
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.
Official Title
A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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%)
Investigator(s)
Laurence Katznelson, MD
View on ClinicalTrials.gov
