UKINETS2016 Oral Communications (1) (3 abstracts)
Efficacy and safety of telotristat etiprate in patients with carcinoid syndrome not adequately controlled by somatostatin analog therapy: Analysis of the ongoing TELESTAR extension period
D Horsch 1 , M Kulke 2 , M Caplin 3 , L Anthony 4 , E Bergsland 5 , K Oberg 6 , S Welin 6 , R Warner 7 , C Lombard-Bohas 8 , P Kunz 9 , J Valle 10 , D Fleming 11 , P Lapuerta 12 , P Banks 13 & M Pavel 14
1Zentralklinik Bad Berka, Bad Berka, Germany; 2Dana-Farber Cancer Institute, Boston, USA; 3Royal Free Hospital, London, UK; 4University of Kentucky, Lexington, USA; 5UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, USA; 6Uppsala University, Uppsala, Sweden; 7Uppsala University, Uppsala, USA; 8Hôpital Edouard Herriot, Hospices Civils de Lyon, New York, France; 9Stanford University, Lyon, USA; 10Stanford University, Manchester, UK; 11The University of Manchester/The Christie NHS Foundation Trust, Manchester, USA; 12Lexicon Pharmaceuticals Inc., The Woodlands, TX, USA; 13Charitè –Universitätsmedizin, Berlin, Germany.
Introduction: TELESTAR was a pivotal, randomized phase 3 study evaluating telotristat etiprate (TE), a tryptophan hydroxylase inhibitor, among patients (pts) with carcinoid syndrome (CS). When added to somatostatin analogues (SSA), 250 mg tid and 500 mg tid TE each produced significantly greater bowel movement (BM) frequency reduction averaged over 12 weeks (wks) than placebo (PBO) plus SSA (P<0.001). Pts crossed over to open-label (OL) treatment with TE 500 mg tid after Wk 12. The extension phase (Wk 13 to Wk 48) is still ongoing. Aim(s): Examine initial efficacy and safety in the crossover (CO) to OL TE. Materials and methods: Changes from baseline (CFB) in BMs/day were examined at Wks 12, 24, and 36, and safety was reviewed.
Results: Among 135 randomized pts, baseline BMs/day (prior to Wk 1) were 5.2, 6.3, and 6.0 respectively on PBO, 250 mg and 500 mg tid. At Wk 12, CFB were −0.9 (PBO), −1.7 (TE 250 mg), and −2.1 (TE 500 mg) (n=108 pts with BM data). 115 pts entered the extension, and at Wk 24, CFB were −1.8, −2.1, and −2.1 (n=98), and at Wk 36 CFB were −1.8, −2.2, and −1.9 (n=73), respectively, in pts originally assigned to PBO, 250 mg tid, and 500 mg tid TE. The Wk 12 CO to 500 mg tid TE was well tolerated. No safety signals were observed with the CO.
Conclusion: Decreases in BM frequency were observed in pts who received TE 500 mg tid after crossing over from either PBO or 250 mg and were sustained in those on 500 mg. BM reduction and favorable safety were observed in pts treated beyond Wk 12. Keywords: telotristat, carcinoid syndrome, tryptophan
Volume 46
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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