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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)

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sandostatin LAR
pegvisomant
cabergoline
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Sandostatin LAR, High Dose, GH-receptor antagonist, combination with dopamine-agonist, acromegalic patients, octreotide acetate, Somavert, Dostinex, pegvisomant, cabergoline, not adequately controlled, active acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novarts Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Sandostatin LAR high dose Alone

Sandostatin LAR high dose + Pegvisomat

Sandostatin LAR high dose + Cabergoline

Arm 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.

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

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: 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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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.

Full Information

First Posted
January 14, 2011
Last Updated
February 28, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01278342
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Sandostatin LAR, High Dose, GH-receptor antagonist, combination with dopamine-agonist, acromegalic patients, octreotide acetate, Somavert, Dostinex, pegvisomant, cabergoline, not adequately controlled, active acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sandostatin LAR high dose Alone
Arm Type
Active Comparator
Arm 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.
Arm Title
Sandostatin LAR high dose + Pegvisomat
Arm Type
Experimental
Arm 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
Arm Title
Sandostatin LAR high dose + Cabergoline
Arm Type
Experimental
Arm 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: 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)
Intervention Type
Drug
Intervention Name(s)
Sandostatin LAR
Other Intervention Name(s)
octreotide acetate
Intervention Description
40 mg intramuscular (i.m.) every 28 days for 3 months
Intervention Type
Drug
Intervention Name(s)
pegvisomant
Other Intervention Name(s)
Somavert, octreotide acaetate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
cabergoline
Other Intervention Name(s)
Dostinex, octreotide acetate
Intervention Description
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)
Primary Outcome Measure Information:
Title
The Percentage of Participants With Complete Response (CR) at 8 Months
Description
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).
Time Frame
From Baseline to 8 months
Secondary Outcome Measure Information:
Title
The Percentage of Participants With Complete Response (CR) At 3 Months
Description
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)
Time Frame
From Baseline to 3 months
Title
The Percentage of Participants With Partial Response (PR) at 8 Months
Description
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.
Time Frame
From Baseline to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Novartis Investigative Site
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Novartis Investigative Site
City
Kremlin-Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Novartis Investigative Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Novartis Investigative Site
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Novartis Investigative Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Novartis Investigative Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novarts Investigative Site
City
Naples
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
91-425
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
Country
Poland
Facility Name
Novartis Investigative Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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