Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
- Conditions
- Acromegaly
- Interventions
- Registration Number
- NCT01278342
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I \[IGF I\]) of acromegalic patients not achieving biochemical normalization at conventional regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)
- Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level
- Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion
- Newly diagnosed or previously medically untreated acromegalic patient
- Concomitant treatment with GH-receptor antagonist
- Concomitant treatment with dopamine-agonist
- Symptomatic cholelithiasis or choledocolithiasis
- Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory)
- Previous gamma-knife radiotherapy for treatment of acromegaly
- Compression of the optic chiasm causing visual field defect
- Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sandostatin LAR high dose + Pegvisomat pegvisomant All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months Sandostatin LAR high dose Alone Sandostatin LAR All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months. Sandostatin LAR high dose + Pegvisomat Sandostatin LAR All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months Sandostatin LAR high dose + Cabergoline Sandostatin LAR All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows: 1. st week: 0.25 mg twice a week (0.50 mg/week) 2. nd week: 0.50 mg/week twice a week (1 mg/week) 3. rd week: 0.50 mg four times a week (2 mg/week) 4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week) Sandostatin LAR high dose + Cabergoline cabergoline All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows: 1. st week: 0.25 mg twice a week (0.50 mg/week) 2. nd week: 0.50 mg/week twice a week (1 mg/week) 3. rd week: 0.50 mg four times a week (2 mg/week) 4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
- Primary Outcome Measures
Name Time Method The Percentage of Participants With Complete Response (CR) at 8 Months From Baseline to 8 months A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:
* Mean 1 hour GH \< 2.5µg/L (according to Central Laboratory); and
* IGF-I within the Central Laboratory Normal Range (for age and gender).
- Secondary Outcome Measures
Name Time Method The Percentage of Participants With Complete Response (CR) At 3 Months From Baseline to 3 months A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:
* Mean 1 hour GH \< 2.5µg/L (according to Central Laboratory); and
* IGF-I within the Central Laboratory Normal Range (for age and gender)The Percentage of Participants With Partial Response (PR) at 8 Months From Baseline to 8 months Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.
* Mean 1 hour GH \> 2.5 µg/L and \< 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range.
* Mean 1 hour GH \< 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range.
Trial Locations
- Locations (2)
Novarts Investigative Site
🇮🇹Naples, Italy
Novartis Investigative Site
🇨🇭Lausanne, Switzerland