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 (HOSCAR)

Novartis

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Drug: Sandostatin LAR; Drug: cabergoline; Drug: pegvisomant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278342

2005-005852-42 (Registry Identifier)

CSMS995BIC03

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Sandostatin LAR high dose Alone

Active Comparator group

Description:

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.

Treatment:

Drug: Sandostatin LAR

Sandostatin LAR high dose + Pegvisomat

Experimental group

Description:

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

Treatment:

Drug: pegvisomant

Drug: Sandostatin LAR

Sandostatin LAR high dose + Cabergoline

Experimental group

Description:

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)

Treatment:

Drug: cabergoline

Drug: Sandostatin LAR