Acromegaly
Conditions
Keywords
Growth hormone (GH), IGF-1, Acromegaly, Pituitary adenoma, Brain tumor, Brain cancer, Octreotide acetate
Brief summary
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
Interventions
DRUGOctreotide acetate and cabergoline/Octrotide and Somavert
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS) | 8 months |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed