Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study

Journal article


Publication Details

Author(s): Pavel ME, Borson-Chazot F, Cailleux A, Hoersch D, Lahner H, Pivonello R, Tauchmanova L, Darstein C, Olsson H, Tiberg F, Ferone D
Journal: Cancer Chemotherapy and Pharmacology
Publication year: 2019
Volume: 83
Journal issue: 2
Pages range: 375-385
ISSN: 0344-5704


Abstract

PurposeOctreotide SC depot is a novel, ready-to-use formulation administered via a thin needle. In a phase 1 study in healthy volunteers, this formulation provided higher bioavailability of octreotide with faster onset and stronger suppression of IGF-1 in healthy volunteers versus long-acting intramuscular (IM) octreotide. This phase 2 study evaluated the pharmacokinetics, efficacy, and safety of octreotide SC depot in patients with acromegaly and functioning NETs, previously treated with octreotide IM.MethodsAdult patients with acromegaly or functioning NETs treated for 2 months with octreotide IM [10/20/30mg every 4 weeks (q4w)] received the last dose of octreotide IM treatment in study period 0 and were randomized 28 days later to receive octreotide SC depot 10mg q2w, or 20mg q4w for 3 months (period 1). The primary objective was to characterize the PK profile of octreotide SC depot after each injection vs PK for octreotide IM (period 0).ResultsTwelve patients were randomized to receive octreotide SC depot 10mg q2w (acromegaly n=3; NET n=1) or 20mg q4w (acromegaly n=4; NET n=4). Plasma levels of octreotide were higher with octreotide SC depot as compared to octreotide IM. Adverse events were reported in 6 and 8 patients during period 0 and period 1, respectively; most common in period 1 were gastrointestinal disorders.ConclusionOctreotide SC depot provided higher exposure (AUC) than octreotide IM, maintained biochemical control in patients with acromegaly and symptom control in patients with functioning NETs, and was well tolerated with a safety profile consistent with octreotide IM.ClinicalTrials.gov identifierNCT02299089.


FAU Authors / FAU Editors

Pavel, Marianne Ellen
Medizinische Klinik 1 - Gastroenterologie, Pneumologie und Endokrinologie


External institutions with authors

Camurus AB
Hospital Center University Rouen / Centre hospitalier universitaire de Rouen (CHU)
Novartis AG
Università degli Studi di Napoli Federico II
Universitätsklinikum Essen
Université Claude Bernard Lyon 1 (UCB)
University of Genova / Università degli Studi di Genova
Zentralklinikum Bad Berka


How to cite

APA:
Pavel, M.E., Borson-Chazot, F., Cailleux, A., Hoersch, D., Lahner, H., Pivonello, R.,... Ferone, D. (2019). Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study. Cancer Chemotherapy and Pharmacology, 83(2), 375-385. https://dx.doi.org/10.1007/s00280-018-3734-1

MLA:
Pavel, Marianne Ellen, et al. "Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study." Cancer Chemotherapy and Pharmacology 83.2 (2019): 375-385.

BibTeX: 

Last updated on 2019-12-03 at 00:08