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

Study Overview
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Brief Summary
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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
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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

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: CAM2029 (octreotide subcutaneous depot)


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAM2029 (octreotide subcutaneous depot)<br>CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available. | Drug: CAM2029 (octreotide subcutaneous depot)<br>* Octreotide subcutaneous depot for monthly injections in acromegaly patients<br>* Other names: CAM2029;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of adverse events (AEs) |  | Week 0-52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN |  | Week 50 to 52 | 
| Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L |  | Week 50 to 52 | 
| Proportion of patients/partners declared competent by a healthcare professional to administer intervention | During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place | Week 0-52 | 
| Octreotide plasma concentrations over time |  | Week 0-52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly, octreotide, CAM2029, phase 3