Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.

Official Title
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Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: BIM 23A760


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IGF-1 ≥1.3 x upper limit normal (ULN) Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT) Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels. Exclusion Criteria: The patient has received long acting somatostatin analogues within 6 months of study entry The patient has undergone radiotherapy at any time prior to study entry The time between pituitary surgery (if any) and study entry is less than 6 weeks The patient suffers from macroadenoma with visual field defects due to chiasmatic compression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: BIM 23A760 1 mg<br> | Drug: BIM 23A760<br>* Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.<br>|
| Experimental: BIM 23A760 2 mg<br> | Drug: BIM 23A760<br>* Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.<br>|
| Experimental: BIM 23A760 4 mg<br> | Drug: BIM 23A760<br>* Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.<br>|
| Experimental: BIM 23A760 6 mg<br> | Drug: BIM 23A760<br>* Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 |  | At Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 |  | At Month 3 | 
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 |  | At Month 1 | 
| Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline | 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6 | 
| Changes in IGF-1 |  | Baseline (Day 1) and Month 6 | 
| Percentage Change in Ring Finger Circumference | Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline. | Baseline (Day 1) and Month 6 | 
| Number of Subjects Reported Adverse Events During the Study | For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study. | Up to Visit 10 (An average of 6.5 Months) |