Phase 3
N=358
Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT00600886 ↗Enrolled (actual)
358
Serious AEs
17.1%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 — 31.3; 19.2; 39.4; 21.8 Percentage of Participants — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pasireotide (Drug); Octreotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 |
31.3; 19.2; 39.4; 21.8; 25.7; 17.3 | 0.007 sig |
| SECONDARY Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L |
49.4; 43.4; 45.5; 47.8; 42.6; 46.2 | — |
| SECONDARY Change From Baseline in Tumor Volume at 12 Months |
2420.7; 2259.2; -39.7; -38.0; 2185.2; 2196.5 | — |
| SECONDARY Percentage of Participants With Normalization of IGF-1 |
35.2; 25.3; 35.8; 24.2; 34.1; 28.0 | — |
| SECONDARY Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 |
30.1; 21.4; 30.1; 19.8; 27.8; 23.1 | — |
| SECONDARY Summary of Mean GH Values |
21.9; 18.8; 6.3; 5.8; 5.6; 5.2 | — |
| SECONDARY Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) ) |
12.6; 12.4 | — |
| SECONDARY Severity Scores of Acromegaly Symptoms |
0.9; 1.0; 1.2; 1.4; 1.1; 1.3 | — |
| SECONDARY Ring Size |
11.6; 11.8; 11.7; 12.4; 12.5; 11.4 | — |
| SECONDARY Health-related Quality-of-life as Measured by the AcroQoL Questionnaire |
58.4; 55.6; 65.7; 61.6; 69.3; 62.9 | — |
| SECONDARY Summary of Prolactin Levels |
20.6; 15.8; 8.9; 11.7; 5.4; 6.7 | — |
| SECONDARY Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32) |
64.4; 64.6 | — |
| SECONDARY Pasireotide Trough Concentrations by Incident Dose |
4.65; 6.65; 2.88; 7.81; 3.39; 8.70 | — |
| SECONDARY Octreotide Trough Concentrations by Incident Dose |
0.86; 0.61; 1.21; 0.62; 1.29; 0.19 | — |
| SECONDARY Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover |
17.3; 2.6; 21.0; 2.6; 22.2; 5.3 | — |
| SECONDARY Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L |
49.4; 43.4; 45.5; 47.8; 42.6; 46.2 | — |
| SECONDARY Percentage of Participants With Normalization of IGF-1 |
35.2; 25.3; 35.8; 24.2; 34.1; 28.0 | — |
| SECONDARY Change From Baseline in Tumor Volume |
2420.7; 2259.2; 1614.1; 1565.4; 1482.4; 1390.4 | — |
| SECONDARY Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover |
49.4; 28.9; 43.2; 31.6; 54.3; 31.6 | — |
| SECONDARY Percentage of Participants With Normalization of IGF-1 After Crossover |
19.8; 7.9; 30.9; 7.9; 29.6; 10.5 | — |
| SECONDARY Summary of Mean GH Values After Crossover |
5.9; 7.1; 5.9; 9.8; 4.8; 9.8 | — |
| SECONDARY Change From Extension Baseline in Tumor Volume After Crossover |
1420.9; 1809.6; 1027.5; 1794.9; -18.1; -12.3 | — |
| SECONDARY Severity Scores of Acromegaly Symptoms After Crossover |
0.6; 0.4; 0.5; 0.7; 0.8; 0.7 | — |
| SECONDARY Ring Size After Crossover |
11.2; 11.0; 11.6; 12.3; 11.4; 12.4 | — |
| SECONDARY Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover |
58.9; 59.8; 60.3; 61.2 | — |
| SECONDARY Summary of Prolactin Levels After Crossover |
11.9; 15.7; 7.5; 16.1 | — |
Summary
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.
The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.
Following one year of treatment patients could proceed into the study extension.
Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.
Eligibility Criteria
Inclusion criteria
- Patients with active acromegaly (based on elevated GH and IGF-1 levels)
- Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
- Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity
Exclusion criteria
- Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
- Patients with compression of the optic chiasm causing any visual field defect
- Patients who have received pituitary irradiation within the last ten years prior to visit 1
- Poorly controlled diabetic patients
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00600886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.