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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Camurus AB
• Treatments: Octreotide

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 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%)