Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

Study Overview
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Brief Summary
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This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy

Official Title
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A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Octreotide acetate and cabergoline/Octrotide and Somavert


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male and female patients (> 18 years) with prior surgery of micro- or macroadenoma of the pituitary. At least 6 months chronic treatment with 30mg octreotide (long acting release). Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH- and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used. Lack of suppression of GH nadir to < 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient. Patient's written informed consent. Exclusion criteria: Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass. Radiotherapy planned or radiotherapy for acromegaly within the last 2 years. Symptomatic cholelithiasis that is clinically relevant. Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists. Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis. Other protocol-defined inclusion/exclusion criteria may apply

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: SMS995 + Carbegolin, Somavert + SMS995<br> | Drug: Octreotide acetate and cabergoline/Octrotide and Somavert<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS) |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of tumor size |  | 8 months | 
| Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values |  | 8 months | 
| Control clinical of symptoms of acromegaly |  | 8 months | 
| Quality of Life assessment |  | 8 months | 
| Safety and tolerability as assessed by frequency of AEs |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth hormone (GH), IGF-1, Acromegaly, Pituitary adenoma, Brain tumor, Brain cancer, Octreotide acetate