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

Marianne Pavel, Françoise Borson-Chazot, Anne Cailleux, Dieter Hörsch, Harald Lahner, Rosario Pivonello, Libuse Tauchmanova, Christelle Darstein, Håkan Olsson, Fredrik Tiberg, Diego Ferone

Research output: Contribution to journalArticle

Abstract

Purpose: Octreotide 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. Methods: Adult patients with acromegaly or functioning NETs treated for ≥ 2 months with octreotide IM [10/20/30 mg 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 10 mg q2w, or 20 mg 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). Results: Twelve patients were randomized to receive octreotide SC depot 10 mg q2w (acromegaly n = 3; NET n = 1) or 20 mg 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. Conclusion: Octreotide 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 identifier: NCT02299089.

Original languageEnglish
JournalCancer Chemotherapy and Pharmacology
DOIs
Publication statusAccepted/In press - Jan 1 2018

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Acromegaly
Octreotide
Neuroendocrine Tumors
Multicenter Studies
Tumors
Healthy Volunteers
Safety
Pharmacokinetics

Keywords

  • Acromegaly
  • Carcinoid syndrome
  • Neuroendocrine tumor (NET)
  • Octreotide SC depot
  • Subcutaneous injection

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors : a phase 2, multicenter study. / Pavel, Marianne; Borson-Chazot, Françoise; Cailleux, Anne; Hörsch, Dieter; Lahner, Harald; Pivonello, Rosario; Tauchmanova, Libuse; Darstein, Christelle; Olsson, Håkan; Tiberg, Fredrik; Ferone, Diego.

In: Cancer Chemotherapy and Pharmacology, 01.01.2018.

Research output: Contribution to journalArticle

Pavel, M, Borson-Chazot, F, Cailleux, A, Hörsch, D, Lahner, H, Pivonello, R, Tauchmanova, L, Darstein, C, Olsson, H, Tiberg, F & Ferone, D 2018, 'Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study', Cancer Chemotherapy and Pharmacology. https://doi.org/10.1007/s00280-018-3734-1
Pavel, Marianne ; Borson-Chazot, Françoise ; Cailleux, Anne ; Hörsch, Dieter ; Lahner, Harald ; Pivonello, Rosario ; Tauchmanova, Libuse ; Darstein, Christelle ; Olsson, Håkan ; Tiberg, Fredrik ; Ferone, Diego. / Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors : a phase 2, multicenter study. In: Cancer Chemotherapy and Pharmacology. 2018.
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AU - Pavel, Marianne

AU - Borson-Chazot, Françoise

AU - Cailleux, Anne

AU - Hörsch, Dieter

AU - Lahner, Harald

AU - Pivonello, Rosario

AU - Tauchmanova, Libuse

AU - Darstein, Christelle

AU - Olsson, Håkan

AU - Tiberg, Fredrik

AU - Ferone, Diego

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KW - Carcinoid syndrome

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KW - Subcutaneous injection

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