Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.

Official Title
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Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: C2L-OCT-01 PR, 30 mg
* Drug: Octreotide acetate prolonged release, 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be diagnosed with active acromegaly. If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry. If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry. If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable. If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age. If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication. The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions. Exclusion Criteria: Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating. Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry. Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients Subject who have any other condition that alters the growth hormone or IGF-1 levels. Subjects with signs or symptoms related to a tumor compression of the optical chiasm.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: C2L-OCT-01 PR, 30 mg<br>* Administered by deep IM injection (gluteus) on days 1 and 42<br>|
| Active Comparator: B<br> | Drug: Octreotide acetate prolonged release, 30 mg<br>* Administered by deep IM (gluteus) on Days 1, 28 and 56<br>* Other names: Sandostatin LAR, 30 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg |  | Days 1, 28, 42, 56 and 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR |  | 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly