Phase 3
N=198
Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT01137682 ↗Enrolled (actual)
198
Serious AEs
27.8%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. — 15.4; 20.0; 0 percentage of participants — p=0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pasireotide (Drug); octreotide LAR 30mg (Drug); lanreotide ATG 120mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. |
15.4; 20.0; 0 | 0.0006 sig |
| SECONDARY Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) |
19.3; 25.9; 19.4; 17.5; 25.9; 19.4 | — |
| SECONDARY Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). |
33.3; 29.0; 25.8; 29.8; 33.3; 22.6 | — |
| SECONDARY Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) |
38.6; 55.6; 33.9; 40.4; 44.4; 43.5 | — |
| SECONDARY Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) |
10.5; 16.7; 6.5; 8.8; 14.8; 8.1 | — |
| SECONDARY Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) |
14.0; 27.8; 8.1; 14.0; 22.2; 9.7 | — |
| SECONDARY Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) |
-0.8; -6.4; -0.6; -7.2 | — |
| SECONDARY Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) |
-7.9; -6.9; -8.4; -9.0; -4.5; -3.0 | — |
| SECONDARY Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) |
0.7; -1.1; -0.7; -1.1 | — |
| SECONDARY Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) |
-0.8; -1.4; -0.9; -0.9; -1.3; -0.9 | — |
| SECONDARY Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) |
29.1; 26.9; 24.9 | — |
| SECONDARY Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly |
112.3; 65.3; 95.1 | — |
| SECONDARY Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) |
3.5; 2.3; 2.4; 2.5; 3.0; 1.9 | — |
| SECONDARY Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) |
4.2; 2.9; 0.8; 5.6; 4.8; 3.3 | — |
| SECONDARY Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) |
5.70; 8.66; 14.06; 9.28; 10.32; 14.96 | — |
Summary
This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.
Eligibility Criteria
Inclusion Criteria
- Patients with written informed consent prior to any study related activity
- Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
- Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg
- Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
- Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension
Exclusion Criteria
- Patients who had received pasireotide (SOM 230) prior to enrolment
- Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
- Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
- Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
- Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
- Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
- Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
Data sourced from ClinicalTrials.gov (NCT01137682). 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.