Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

Phase 3 Completed 125 enrolled Ipsen

NaSingle-groupOpen-labelTreatment

Summary

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

Timeline

Start: 2006-10
Primary completion: 2008-10
Completion: 2008-10

Outcome

Mixed primary results

paper coadministration (P<0.0001 versus 30% minimum clinically relevant) PMID 21148630 ↗

registry analysis (other test); Lanreotide Autogel + Pegvisomant Co-administration; p = 0.1654; Exact test; note: One-sided p value NCT00383708 ↗

registry analysis (other test); Lanreotide Autogel + Pegvisomant Co-administration; p = 0.084; Exact test; note: One-sided p value NCT00383708 ↗

Publications

Results van der Lely AJ, Bernabeu I, Cap J, Caron P, Colao A, Marek J, Neggers S, Birman P. Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone. Eur J Endocrinol. 2011 Mar;164(3):325-33. doi: 10.1530/EJE-10-0867. Epub 2010 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lanreotide	Other / unclassified	120 mg	Subcutaneous
Subject	Pegvisomant	Protein / enzyme biologic	40 mg	Subcutaneous
Subject	Pegvisomant	Protein / enzyme biologic	120 mg	Subcutaneous