AcromegalyPhase 4HOSCARNCT01278342
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
A Phase 4 study testing Sandostatin LAR, pegvisomant and cabergoline in people with Acromegaly, run by Novartis Pharmaceuticals at 20 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Sandostatin LAR, pegvisomant and cabergoline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Sep 2006to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
France7 sites
Novartis Investigative Site
Brest, 29609
Novartis Investigative Site
Bron, 69677
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Nîmes, 30029
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Toulouse, 31059
Italy7 sites
Novartis Investigative Site
Genova, 16132
Novartis Investigative Site
Naples, 80131
Novarts Investigative Site
Naples
Novartis Investigative Site
Padova
Novartis Investigative Site
Perugia, 06126
Novartis Investigative Site
Pisa, 56124
Novartis Investigative Site
Torino, 10126
Poland4 sites
Novartis Investigative Site
Lodz, 91-425
Novartis Investigative Site
Warsaw
Novartis Investigative Site
Wroclaw
Novartis Investigative Site
Zabrze, 41-800
About this study
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
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.
- Conditions
- Acromegaly
- Being tested
- Sandostatin LAR, pegvisomant, cabergoline
- 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
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandostatin LARDrug
Also called octreotide acetate
40 mg intramuscular (i.m.) every 28 days for 3 months
pegvisomantDrug
Also called Somavert, octreotide acaetate
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
cabergolineDrug
Also called Dostinex, octreotide acetate
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)
| Study group | Role | What they receive |
|---|---|---|
| Sandostatin LAR high dose Alone | Active comparator | 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. Receives: Drug: Sandostatin LAR |
| Sandostatin LAR high dose + Pegvisomat | Experimental | 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 Receives: Drug: Sandostatin LAR; Drug: pegvisomant |
| Sandostatin LAR high dose + Cabergoline | Experimental | 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) Receives: Drug: Sandostatin LAR; Drug: cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Baseline to 8 months
Secondary outcomes (2)
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)
Measured: From Baseline to 3 months
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.
Measured: From Baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startSep 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278342
- Sponsor's protocol ID
- CSMS995BIC03
- Other IDs
- 2005-005852-42, 2005
- Acronym
- HOSCAR
- Status last verified
- Feb 2017
- First submitted
- 14 Jan 2011
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01278342
- Acronym / sponsor ID
- HOSCAR / CSMS995BIC03
- Conditions
- Acromegaly
- Keywords
- Sandostatin LAR, High Dose, GH-receptor antagonist, combination with dopamine-agonist, acromegalic patients, octreotide acetate, Somavert, Dostinex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Posted 17 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sandostatin LAR high dose Alone | Active comparator | Drug: Sandostatin LARAll 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. |
| Sandostatin LAR high dose + Pegvisomat | Experimental | Drug: Sandostatin LAR, Drug: pegvisomantAll 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 |
| Sandostatin LAR high dose + Cabergoline | Experimental | Drug: Sandostatin LAR, Drug: cabergolineAll 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandostatin LARAlso: octreotide acetate40 mg intramuscular (i.m.) every 28 days for 3 months | Drug | Sandostatin LAR high dose + Cabergoline, Sandostatin LAR high dose + Pegvisomat, Sandostatin LAR high dose Alone |
| pegvisomantAlso: Somavert, octreotide acaetateWeekly 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 | Drug | Sandostatin LAR high dose + Pegvisomat |
| cabergolineAlso: Dostinex, octreotide acetateWeekly 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) | Drug | Sandostatin LAR high dose + Cabergoline |
Primary outcome
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).
2 secondary outcomes
The Percentage of Participants With Complete Response (CR) At 3 Months
Time frame: From Baseline to 3 months
The Percentage of Participants With Partial Response (PR) at 8 Months
Time frame: From Baseline to 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sandostatin LAR, pegvisomant and cabergoline in people with Acromegaly, run by Novartis Pharmaceuticals at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Italy, Poland, Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Participants With Complete Response (CR) at 8 Months (time frame: From Baseline to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.