Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Study Overview
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Brief Summary
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Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.

Detailed Description
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This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.

Official Title
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Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Octreotide Implant
* Drug: Sandostatin LAR Depot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients with acromegaly Confirmed diagnosis of a growth hormone-secreting tumor Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 < 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL Exclusion Criteria: Patients with pituitary surgery less than 3 months prior to screening Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9% Symptomatic cholelithiasis Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>84 mg octreotide implant for 6 months | Drug: Octreotide Implant<br>* 84 mg octreotide subcutaneous implant for 6 months<br>* Other names: somatostatin analogue;|
| Active Comparator: 2<br>Injections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks | Drug: Sandostatin LAR Depot<br>* Injections of Sandostatin LAR (dose range  10-40 mg every 28 days)<br>* Other names: somatostatin analogue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Octreotide, Sandostatin LAR, Growth hormone, IGF-1