A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Launched by CAMURUS AB · Oct 11, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a medication called CAM2029 for patients with acromegaly, a condition caused by too much growth hormone. Participants in the study will receive CAM2029 as an injection under the skin once a month for a year. If they complete the initial part of the trial, they may have the option to continue receiving the treatment for an additional 52 weeks.

To be eligible for this trial, patients must be adults aged 18 or older, have a confirmed diagnosis of acromegaly, and have been on stable doses of certain treatments for at least three months. They also need to have specific hormone levels within a certain range and good overall health. Throughout the trial, participants will be monitored regularly to ensure their safety and to see how well the treatment works. It's important to note that some individuals with recent surgeries, specific health conditions, or certain previous treatments may not be able to participate.

Gender

ALL

Eligibility criteria

• 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%)