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Completed

NCT Number: NCT01278342

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

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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sandostatin LAR

Drug

40 mg intramuscular (i.m.) every 28 days for 3 months

Other names: octreotide acetate

Pegvisomant

Drug

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

cabergoline

Drug

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)

Other names: Dostinex, octreotide acetate

Primary outcomes

  1. The Percentage of Participants With Complete Response (CR) at 8 Months

    Time frame: 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 outcomes

  1. The Percentage of Participants With Complete Response (CR) At 3 Months

    Time frame: 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)

  2. The Percentage of Participants With Partial Response (PR) at 8 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: HOSCAR

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 17, 2011
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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