Axitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinoma

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F15%3A33155454" target="_blank" >RIV/61989592:15110/15:33155454 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1093/annonc/mdv103" target="_blank" >http://dx.doi.org/10.1093/annonc/mdv103</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/annonc/mdv103" target="_blank" >10.1093/annonc/mdv103</a>

Result language

angličtina

Original language name

Axitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinoma

Original language description

Background: In a randomized, double- blind phase II trial in patients with metastatic renal cell carcinoma ( mRCC), axitinib versus placebo titration yielded a significantly higher objective response rate. We evaluated pharmacokinetic and blood pressure( BP) data from this study to elucidate relationships among axitinib exposure, BP change, and efficacy. Patients and methods: Patients received axitinib 5 mg twice daily during a lead- in period. Patients who met dose- titration criteria were randomized1: 1 to stepwise dose increases with axitinib or placebo. Patients ineligible for randomization continued without dose increases. Serial 6- h and sparse pharmacokinetic sampling were carried out; BP was measured at clinic visits and at home in all patients, and by 24- h ambulatory BP monitoring ( ABPM) in a subset of patients. Results: Area under the plasma concentration- time curve from 0 to 24 h throughout the course of treatment ( AUCstudy) was higher in patients with complete or part

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FD - Oncology and haematology

OECD FORD branch

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Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Annals of Oncology

ISSN

0923-7534

e-ISSN

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Volume of the periodical

26

Issue of the periodical within the volume

7

Country of publishing house

GB - UNITED KINGDOM

Number of pages

6

Pages from-to

1372-1377

UT code for WoS article

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EID of the result in the Scopus database

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