About: Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer     Goto   Sponge   NotDistinct   Permalink

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  • The activity of vandetanib plus docetaxel was assessed in patients with previously treated non-small-cell lung cancer (NSCLC) This two-part study comprised an open-label run-in phase and a double-blind randomized phase. Eligible patients had locally advanced or metastatic (stage IIIB/IV) NSCLC after failure of first-line platinum-based chemotherapy. The primary objective of the randomized phase was to prolong progression-free survival (PFS) in patients receiving vandetanib (100 or 300 mg/d) plus docetaxel (75 mg/m2 intravenous infusion every 21 days) versus placebo plus docetaxel. There was no statistically significant difference in overall survival among the three treatment arms. Common adverse events included diarrhea, rash, and asymptomatic prolongation of corrected QT (QTC) interval. The primary objective was achieved, with vandetanib 100 mg plus docetaxel demonstrating a significant prolongation of PFS compared with docetaxel in relation to the prespecified significance level.
  • The activity of vandetanib plus docetaxel was assessed in patients with previously treated non-small-cell lung cancer (NSCLC) This two-part study comprised an open-label run-in phase and a double-blind randomized phase. Eligible patients had locally advanced or metastatic (stage IIIB/IV) NSCLC after failure of first-line platinum-based chemotherapy. The primary objective of the randomized phase was to prolong progression-free survival (PFS) in patients receiving vandetanib (100 or 300 mg/d) plus docetaxel (75 mg/m2 intravenous infusion every 21 days) versus placebo plus docetaxel. There was no statistically significant difference in overall survival among the three treatment arms. Common adverse events included diarrhea, rash, and asymptomatic prolongation of corrected QT (QTC) interval. The primary objective was achieved, with vandetanib 100 mg plus docetaxel demonstrating a significant prolongation of PFS compared with docetaxel in relation to the prespecified significance level. (en)
  • Aktivita vandetanibu s docetaxelem byla hodnocena u pacientů po předchozí léčbě pro nemalobuněčný plicní karcinom ( NSCLC). Tato dvoudílná studie zahrnovala otevřenou vstupní část a dvojitě zaslepenou randomizovanou fázi. Randomizováni byli pacienti s lokálně pokročilým nebo metastatickým (stádium IIIB/IV) NSCLC po selhání první linie chemoterapie s cisplatinou. Primárním cílem pro randomizovanou fázi bylo prodloužení času do progrese ( PFS) u pacientů léčených vandetanibem (100 nebo 300 mg/den) a docetaxelem ( 75 mg/m2 i.v. infúzi každých 21 dní) oproti placebu s docetaxelem. Nebyl zjištěn žádný statisticky signifikantní rozdíl v celkovém přežití mezi všemi třemi rameny. Obecnými nežádoucími účinky byl průjem, rash, asymtpomatické prodloužení korigovaného QT (QTC) intervalu. Primární cíl byl dosažen v rameni s vandetanibem 100 mg a docetaxelem v signifikantním prodloužení času do progrese ve srovnání se samotným docetaxelem. (cs)
Title
  • Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer
  • Randomizovaná placebem kontrolovaná fáze II studie vandetanib plus docetaxel u pacientů s nemalobuněčnou plicní rakovinou po selhání předchozí léčby (cs)
  • Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer (en)
skos:prefLabel
  • Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer
  • Randomizovaná placebem kontrolovaná fáze II studie vandetanib plus docetaxel u pacientů s nemalobuněčnou plicní rakovinou po selhání předchozí léčby (cs)
  • Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer (en)
skos:notation
  • RIV/00843989:_____/07:00014903!RIV09-MZ0-00843989
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • N, V
http://linked.open...iv/cisloPeriodika
  • 27
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 446396
http://linked.open...ai/riv/idVysledku
  • RIV/00843989:_____/07:00014903
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • receptor tyrosine kinase; malignant tumors; supportive care; solid tumors; trial; chemotherapy; gefitinib; erlotinib; bevacizumab; carboplatin (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • US - Spojené státy americké
http://linked.open...ontrolniKodProRIV
  • [54287826F7EA]
http://linked.open...i/riv/nazevZdroje
  • Journal of Clinical Oncology
http://linked.open...in/vavai/riv/obor
http://linked.open...ichTvurcuVysledku
http://linked.open...cetTvurcuVysledku
http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 25
http://linked.open...iv/tvurceVysledku
  • Roubec, Jaromír
  • Pešek, M.
  • Hou, J.
  • Herbst, R. S.
  • Belani, Ch.P.
  • Bodrogi, I.
  • Csada, E.
  • Gadgeel, S.
  • Heymach, J. V.
  • Johnson, B. E.
  • Kennedy, S. J.
  • Prager, D.
  • Špásová, I.
http://linked.open...ain/vavai/riv/wos
  • 000251073200020
issn
  • 0732-183X
number of pages
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