Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors : a phase 2, multicenter study
(2019) In Cancer Chemotherapy and Pharmacology 83(2). p.375-385- 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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2019
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Acromegaly, Carcinoid syndrome, Neuroendocrine tumor (NET), Octreotide SC depot, Subcutaneous injection
- in
- Cancer Chemotherapy and Pharmacology
- volume
- 83
- issue
- 2
- pages
- 375 - 385
- publisher
- Springer
- external identifiers
-
- pmid:30535537
- scopus:85058091026
- ISSN
- 0344-5704
- DOI
- 10.1007/s00280-018-3734-1
- language
- English
- LU publication?
- yes
- id
- 229a2173-d921-4a10-b0ec-29dd517d764b
- date added to LUP
- 2019-01-08 14:06:21
- date last changed
- 2024-04-01 17:05:44
@article{229a2173-d921-4a10-b0ec-29dd517d764b,
abstract = {{<p>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.</p>}},
author = {{Pavel, Marianne and Borson-Chazot, Françoise and Cailleux, Anne and Hörsch, Dieter and Lahner, Harald and Pivonello, Rosario and Tauchmanova, Libuse and Darstein, Christelle and Olsson, Håkan and Tiberg, Fredrik and Ferone, Diego}},
issn = {{0344-5704}},
keywords = {{Acromegaly; Carcinoid syndrome; Neuroendocrine tumor (NET); Octreotide SC depot; Subcutaneous injection}},
language = {{eng}},
number = {{2}},
pages = {{375--385}},
publisher = {{Springer}},
series = {{Cancer Chemotherapy and Pharmacology}},
title = {{Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors : a phase 2, multicenter study}},
url = {{http://dx.doi.org/10.1007/s00280-018-3734-1}},
doi = {{10.1007/s00280-018-3734-1}},
volume = {{83}},
year = {{2019}},
}