A Trial to Assess Efficacy and 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 efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

Official Title
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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and 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)
* Drug: Matching placebo


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 prior to any trial related procedures are performed 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 at screening Adequate liver, pancreatic, renal and bone marrow functions Normal ECG Exclusion Criteria: GH ≥2.5 μg/L at screening (cycle) 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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


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, six months treatment. 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;|
| Placebo Comparator: Matching placebo<br>Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available. | Drug: Matching placebo<br>* Matching placebo for CAM2029<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with mean IGF-1 levels ≤1xULN |  | Week 22 to 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with mean GH levels <2.5 µg/L |  | Week 22 to 24 | 
| Incidence of treatment emergent adverse events and laboratory and ECG abnormalities |  | At every visit, Week 0 to 24 | 
| Proportion of patients/partners declared competent by a healthcare professional to administer intervention | During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place | Week 0 to 20 and week 24 | 
| Octreotide plasma concentrations over time |  | At every visit, Week 0 to 24 | 

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