Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort name HOSCAR
France, Italy, Poland, Portugal, Switzerland
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
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.
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
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)
Outcomes the sponsor listed as primary.
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).
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)
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent) |
|---|---|
| Sandostatin LAR High Dose Alone | 25 |
| Sandostatin LAR High Dose + Pegvisomat | 0 |
| Sandostatin LAR High Dose + Cabergoline | 9.4 |
| Group | Value (percent) |
|---|---|
| Sandostatin LAR High Dose Alone | 60 |
| Sandostatin LAR High Dose + Pegvisomat | 0 |
| Sandostatin LAR High Dose + Cabergoline | 0 |
| Group | Value (percent) |
|---|---|
| Sandostatin LAR High Dose Alone | 25 |
| Sandostatin LAR High Dose + Pegvisomat | 22.6 |
| Sandostatin LAR High Dose + Cabergoline | 21.9 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Sandostatin LAR High Dose AloneAll 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 | – | 0 / 7 | 4 / 7 |
| Sandostatin LAR High Dose + 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, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months. | – | 1 / 32 | 15 / 32 |
| Sandostatin LAR High Dose + 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, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows: * 1st week: 0.25 mg twice a week (0.50 mg/week) * 2nd week: 0.50 mg/week twice a week (1 mg/week) * 3rd week: 0.50 mg four times a week (2 mg/week) * 4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week) | – | 2 / 31 | 12 / 31 |
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