Sökning: onr:"swepub:oai:lup.lub.lu.se:229a2173-d921-4a10-b0ec-29dd517d764b" >
Octreotide SC depot...
Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors : a phase 2, multicenter study
-
- Pavel, Marianne (författare)
- Charité - University Medicine Berlin,Friedrich-Alexander University Erlangen-Nürnberg
-
- Borson-Chazot, Françoise (författare)
- Claude Bernard University Lyon 1
-
- Cailleux, Anne (författare)
- Hopital Charles Nicolle
-
visa fler...
-
- Hörsch, Dieter (författare)
- Central Clinic Bad Berka
-
- Lahner, Harald (författare)
- University Hospital Essen
-
- Pivonello, Rosario (författare)
- University of Naples Federico II
-
- Tauchmanova, Libuse (författare)
- Novartis Pharma AG
-
- Darstein, Christelle (författare)
- Novartis Pharma AG
-
- Olsson, Håkan (författare)
- Camurus AB
-
- Tiberg, Fredrik (författare)
- Lund University,Lunds universitet,Fysikalisk kemi,Enheten för fysikalisk och teoretisk kemi,Kemiska institutionen,Institutioner vid LTH,Lunds Tekniska Högskola,Physical Chemistry,Physical and theoretical chemistry,Department of Chemistry,Departments at LTH,Faculty of Engineering, LTH,Camurus AB
-
- Ferone, Diego (författare)
- University of Genoa,Ospedale Policlinico San Martino
-
visa färre...
-
(creator_code:org_t)
- 2018-12-08
- 2019
- Engelska.
-
Ingår i: Cancer Chemotherapy and Pharmacology. - : Springer Science and Business Media LLC. - 0344-5704 .- 1432-0843. ; 83:2, s. 375-385
- Relaterad länk:
-
http://dx.doi.org/10...
-
visa fler...
-
https://lup.lub.lu.s...
-
https://doi.org/10.1...
-
visa färre...
Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Nyckelord
- Acromegaly
- Carcinoid syndrome
- Neuroendocrine tumor (NET)
- Octreotide SC depot
- Subcutaneous injection
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Pavel, Marianne
-
Borson-Chazot, F ...
-
Cailleux, Anne
-
Hörsch, Dieter
-
Lahner, Harald
-
Pivonello, Rosar ...
-
visa fler...
-
Tauchmanova, Lib ...
-
Darstein, Christ ...
-
Olsson, Håkan
-
Tiberg, Fredrik
-
Ferone, Diego
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Gastroenterologi
- Artiklar i publikationen
-
Cancer Chemother ...
- Av lärosätet
-
Lunds universitet