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

Pavel ME, Borson-Chazot F, Cailleux A, Hoersch D, Lahner H, Pivonello R, Tauchmanova L, Darstein C, Olsson H, Tiberg F, Ferone D (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Cancer Chemotherapy and Pharmacology Springer Verlag (Germany)

Book Volume: 83

Pages Range: 375-385

Journal Issue: 2

DOI: 10.1007/s00280-018-3734-1

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.

Authors with CRIS profile

Marianne Ellen Pavel Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology

Involved external institutions

Université Claude Bernard Lyon 1 (UCB) FR France (FR) Hospital Center University Rouen / Centre hospitalier universitaire de Rouen (CHU) FR France (FR) Zentralklinikum Bad Berka DE Germany (DE) Universitätsklinikum Essen DE Germany (DE) Università degli Studi di Napoli Federico II IT Italy (IT) Novartis AG CH Switzerland (CH) Camurus AB SE Sweden (SE) University of Genova / Università degli Studi di Genova IT Italy (IT)

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.

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