Phase 3
N=128
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT02493517 ↗Enrolled (actual)
128
Serious AEs
2.3%
Results posted
Dec 2018
Primary outcome: Primary: Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit — -0.84; -0.52; 0.43; 0.59 SDS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lanreotide Autogel® (Drug); Lanreotide Acetate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit |
-0.84; -0.52; 0.43; 0.59 | — |
| SECONDARY Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit |
15.6; 9.4 | — |
| SECONDARY Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit |
29.7; 31.3 | — |
| SECONDARY The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit |
10.9; 9.4 | — |
| SECONDARY Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit |
7.8; 3.1 | — |
| SECONDARY Mean Change From Baseline in GH Values at the EOST/EW Visit |
-9.548; -13.182 | — |
| SECONDARY Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline |
45.5; 50.9 | — |
| SECONDARY Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit |
-17.870; -20.120 | — |
| SECONDARY Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline |
70.3; 59.4; 75.0; 59.4 | — |
Summary
The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.
Eligibility Criteria
Inclusion Criteria
- Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a central laboratory) as outlined below:
- A serum level for IGF-1 ≥1.3 x upper limit of normal range (ULN) during the screening period (applicable to both treatment naïve subjects and subjects who have stopped treatment and undergone a washout period prior to Visit 1(Week -4).
- Subjects must have mean serum GH concentration ≥2.5 μg/L in a GH cycle (5 samples taken at 0, 30, 60, 90 and 120 minutes) during the screening period.
- The subject has undergone surgical removal of an adenoma for acromegaly at least 3 months prior to Screening, or is likely to require pituitary surgery in the future but not before completing at least 32 weeks of study treatment plus an additional follow up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for whom pituitary surgery is not an option (due to contraindications, refusal etc.) and is therefore never likely to undergo pituitary surgery.
Exclusion Criteria
- The subject has been treated with radiotherapy within 10 years prior to Screening.
- The subject has been treated with lanreotide Autogel, lanreotide PR, pegvisomant, cabergoline or octreotide LAR within 3 months of Screening or octreotide immediate release (IR) or bromocriptin within 2 weeks of Screening.
- The subject has a history of or currently presents with clinically significant ventricular or atrial dysrhythmias ≥Grade 2, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
- The subject has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8.5%).
Data sourced from ClinicalTrials.gov (NCT02493517). 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.