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本帖最后由 虎光着 于 2018-8-24 18:47 编辑
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. H0 ]- W0 x! }4 nCediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer (HORIZON II)
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Purpose ( {6 y* |, u- b t$ `
The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.% \2 `/ B; h# ]0 [0 r/ }) Q" q8 s& M
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Arms Assigned Interventions
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Placebo Comparator: 1 Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)( h1 E* m% c, c* n# R4 X0 t% V7 `
FOLFOX + placebo intravenous infusion
1 p+ E& p. _& u$ t( q Cediranib ! ?& j$ }5 i/ B3 f+ W* x; u0 n
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Placebo Comparator: 2 Drug: XELOX (Capecitabine and Oxaliplatin)
& I# K% t4 M2 h7 p Xelox+ placebo intravenous oxaliplatin 130 mg/m(2) (day 1) followed by
: O; Q H Y5 [% ^6 m Cediranib oral capecitabine 1,000 mg/m(2) twice daily (day 1 to day 15)
" y# ^+ c5 R3 s Other Name: Xeloda® + Eloxatin®
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' k. v3 T0 }0 ?- l, E/ q! W* Q) cExperimental: 3 Drug: Cediranib
3 H. q$ [" G1 ?, B l5 j FOLFOX + Cediranib Drug: Cediranib oral tablet( B4 E# |0 f4 |5 n' s! v
Other Names:
. Q6 e2 Q2 Q6 |/ T+ q# | AZD2171 6 I6 Q5 B- E% H. e. }
RECENTIN™ + s! Y( G7 T' n+ l5 ^
- |4 D3 v, _) a( `4 g7 j7 m" Z Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) : b' ~0 z" w! m0 w" \+ Y
intravenous infusion o* F6 f+ @8 M3 u. C2 G! `
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8 l( h& z" k$ [' ~4 ^0 ^+ J! O* TExperimental: 4 Drug: Cediranib # \1 `) c1 z! E6 ^1 O
XELOX + Cediranib oral tablet+ F2 L8 [- E. z3 N/ O+ j/ B9 V, L1 e
Other Names:
G* B4 n1 m' q5 ?0 d- R) }* Y AZD2171 % P3 g+ } T5 D. t
RECENTIN™
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Drug: XELOX (Capecitabine and Oxaliplatin)
3 G* L; d# Q1 z intravenous oxaliplatin 130 mg/m(2) (day 1) followed
/ @4 y( _+ ~8 \4 X by oral capecitabine 1,000 mg/m(2) twice daily (day 1 to day 15)6 e6 ]( \7 ?. r9 j; h6 _
Other Name: Xeloda® + Eloxatin®
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7 a# }6 n! Q' e) t0 REnrollment: 1076 ; ]* V7 f3 U- s! {! r
Study Start Date: November 2006
* p( k2 @3 U& `7 x8 ~7 {2 UEstimated Study Completion Date: May 2013
: E, l1 M: X5 ~$ e4 d) Q. oPrimary Completion Date: March 2010 (Final data collection date for primary outcome measure) 2 d. ]# d a0 g+ |
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西地尼布是阿斯利康原本打算在结直肠癌一线联合化疗用药超越阿瓦斯汀的产品，但在两个大型三期实验中都没有达到设计终点，因此阿斯利康已放弃了新药在肠癌一线治疗方面的申请计划。不过在上述HORIZON II实验中，中期的结论中PFS（无病生存期）实质上是超过了阿瓦的PFS而在OS方面没有超过阿瓦。
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AstraZeneca Announces Results of Recentin HORIZON II Phase III Trial in Metastatic Colorectal Cancer
4 b8 t1 b, f) b& R7 aFriday, 28 May 2010
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2 T' g/ i0 n0 x, x1 zAstraZeneca today announced the top-line results of the HORIZON II Phase III study evaluating RECENTIN (cediranib) for the first-line treatment of metastatic colorectal cancer (mCRC). Cediranib met the co-primary endpoint of improving progression-free survival (PFS) but showed no improvement in overall survival (OS).
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The adverse events associated with cediranib during this study were broadly consistent with previous studies. HORIZON II is the second of two pivotal studies of cediranib in first-line mCRC. In March, the HORIZON III study of cediranib plus chemotherapy versus bevacizumab plus chemotherapy did not meet the primary endpoint of PFS.3 G7 V4 n* B; o0 T; L
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Based on the results of these two trials, AstraZeneca does not intend to file regulatory submissions in first-line mCRC.) l/ y. [7 J7 S7 A3 {3 v$ Z( j# V
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The results of a Phase III study evaluating cediranib for the treatment of recurrent glioblastoma (REGAL) are expected soon. In addition, AstraZeneca is currently examining whether cediranib may have applications in a number of different tumour types. ) R% z4 o/ q1 c, S) E' R2 [
* O) ^/ N9 T; e! @# W/ MData from HORIZON II and HORIZON III will be submitted to a forthcoming medical congress.0 [$ r# m8 _) ]' s, `! _/ o
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上述是来自阿斯利康官方网站上的公告。
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