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

Acromegaly Clinical Trial

— HOSCAR  

Official title:

An Open-label, Two-step, Multicenter European 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 Not Adequately Controlled by Conventional Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278342
• Other study ID #: CSMS995BIC03
• Secondary ID: 2005-005852-42
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2011
• Last updated: February 28, 2017
• Start date: September 2006
• Est. completion date: November 2009

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Sandostatin LAR
40 mg intramuscular (i.m.) every 28 days for 3 months
• pegvisomant
Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months
• cabergoline
Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows: st week: 0.25 mg twice a week (0.50 mg/week) nd week: 0.50 mg/week twice a week (1 mg/week) rd week: 0.50 mg four times a week (2 mg/week) th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Locations

Country	Name	City	State
France	Novartis Investigative Site	Brest Cedex
France	Novartis Investigative Site	Bron Cedex
France	Novartis Investigative Site	Kremlin-Bicetre
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Nimes
France	Novartis Investigative Site	Pessac
France	Novartis Investigative Site	Toulouse
Italy	Novartis Investigative Site	Genova
Italy	Novarts Investigative Site	Naples
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Padova
Italy	Novartis Investigative Site	Perugia
Italy	Novartis Investigative Site	Pisa
Italy	Novartis Investigative Site	Torino
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Zabrze
Portugal	Novartis Investigative Site	Porto
Switzerland	Novartis Investigative Site	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

France,  Italy,  Poland,  Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants With Complete Response (CR) at 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).	From Baseline to 8 months
Secondary	The Percentage of Participants With Complete Response (CR) At 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)	From Baseline to 3 months
Secondary	The Percentage of Participants With Partial Response (PR) at 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.	From Baseline to 8 months