Overview

This trial is active, not recruiting.

Condition acromegaly
Treatments lanreotide autogel®, lanreotide acetate
Phase phase 3
Sponsor Ipsen
Start date October 2014
End date November 2016
Trial size 128 participants
Trial identifier NCT02493517, 8-55-52030-289, CTR20140698

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Lanreotide Autogel 90mg from day 1 to week 13, 1 injection every 4 weeks (4 in total), titrated to 60mg, 90mg, or 120mg at week 17, then from week 17 to week 29 each group receives 1 injection every 4 weeks (4 in total/group).
lanreotide autogel®
Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection.
(Active Comparator)
Lanreotide PR 40mg from day 1 to week 15, 1 injection every 10 days, then at dose titration (week 16) injection frequency will either remain at 10 days or increase to 14 days or decrease to 7 days up until week 30 or 31.
lanreotide acetate
Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection.

Primary Outcomes

Measure
Mean change from baseline in age adjusted IGF-1 values expressed as standard deviation scores (SDS).
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)

Secondary Outcomes

Measure
Percentage of subjects with normal age adjusted insulin like growth factor-1 (IGF-1) levels at the end of study treatment (EOST) in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)
Percentage of subjects with growth hormone (GH) ≤2.5 μg/L at the EOST in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)
Percentage of subjects with GH ≤1 μg/L at the EOST in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)
Percentage of subjects with normal age adjusted IGF-1 levels AND 1 μg/L< GH ≤2.5 μg/L at the EOST in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)
Mean change from Baseline in GH values at the EOST in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)
Percentage of subjects presenting with at least a 20% reduction in tumour volume at the EOST compared to Baseline in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)
Mean (±standard deviation (SD)) percentage change from Baseline in tumour volume at the EOST in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)
Percentage of subjects with at least one symptom of acromegaly (headache,excessive perspiration, fatigue, soft tissue swelling and arthralgia) at Week 13 and at the EOST, compared to Baseline in subjects treated with lanreotide Autogel and lanreotide PR
time frame: Day 1, week 13, week 33 (lanreotide Autogel group) or week 32 (lanreotide PR group)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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%).

Additional Information

Official title A Phase III, Prospective, Randomised, Open Label Study to Compare the Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg PR in Subjects With Active Acromegaly
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Ipsen.