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)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01278342
First received: January 14, 2011
Last updated: April 20, 2011
Last verified: April 2011

January 14, 2011
April 20, 2011
September 2006
November 2009   (final data collection date for primary outcome measure)
The Percentage of Participants With Complete Response (CR) at 8 Months [ Time Frame: From Baseline to 8 months ] [ Designated as safety issue: No ]

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).
Growth Hormone (GH) and insulin-like growth factor-I (IGF l) control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01278342 on ClinicalTrials.gov Archive Site
  • The Percentage of Participants With Complete Response (CR) At 3 Months [ Time Frame: From Baseline to 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: From Baseline to 8 months ] [ Designated as safety issue: No ]

    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.
  • biochemical control on high dose SandostatinLAR in mono treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • partial biochemical control under combination of high dose of Sandostatin + combination partner [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
  • Drug: Sandostatin LAR
    40 mg intramuscular (i.m.) every 28 days for 3 months
    Other Name: octreotide acetate
  • Drug: 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
    Other Names:
    • Somavert
    • octreotide acaetate
  • Drug: 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:

    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)
    Other Names:
    • Dostinex
    • octreotide acetate
  • Active Comparator: Sandostatin LAR high dose Alone
    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.
    Intervention: Drug: Sandostatin LAR
  • Experimental: Sandostatin LAR high dose + Pegvisomat
    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
    Interventions:
    • Drug: Sandostatin LAR
    • Drug: pegvisomant
  • Experimental: Sandostatin LAR high dose + 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)
    Interventions:
    • Drug: Sandostatin LAR
    • Drug: cabergoline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2009
November 2009   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Poland,   Portugal,   Switzerland
 
NCT01278342
CSMS995BIC03, 2005-005852-42
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP