Cediranib(西地尼布)

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本帖最后由虎光着于 2018-8-24 18:47 编辑

Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer (HORIZON II)

Purpose
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.

--------------------------------------------------------------------------------------------------------------------------------------------------
Arms                                                                               Assigned Interventions
--------------------------------------------------------------------------------------------------------------------------------------------------
Placebo Comparator: 1                                        Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
      FOLFOX + placebo                                              intravenous infusion
      Cediranib
--------------------------------------------------------------------------------------------------------------------------------------------------
Placebo Comparator: 2                                        Drug: XELOX (Capecitabine and Oxaliplatin)
      Xelox+ placebo                                                 intravenous oxaliplatin 130 mg/m(2) (day 1) followed by
      Cediranib                                                          oral capecitabine 1,000 mg/m(2) twice daily (day 1 to day 15)
                                                                                 Other Name: Xeloda® + Eloxatin®
--------------------------------------------------------------------------------------------------------------------------------------------------
Experimental: 3                                                    Drug: Cediranib
      FOLFOX + Cediranib Drug: Cediranib                   oral tablet
                                                                                 Other Names:
                                                                                          AZD2171
                                                                                          RECENTIN™

                                                                                          Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
                                                                                                intravenous infusion
--------------------------------------------------------------------------------------------------------------------------------------------------
Experimental: 4                                                    Drug: Cediranib
XELOX + Cediranib                                                    oral tablet
                                                                              Other Names:
                                                                                    AZD2171
                                                                                    RECENTIN™

                                                                           Drug: XELOX (Capecitabine and Oxaliplatin)
                                                                                 intravenous oxaliplatin 130 mg/m(2) (day 1) followed
                                                                                 by oral capecitabine 1,000 mg/m(2) twice daily (day 1 to day 15)
                                                                                 Other Name: Xeloda® + Eloxatin®
---------------------------------------------------------------------------------------------------------------------------------------------------

Enrollment: 1076
Study Start Date: November 2006
Estimated Study Completion Date: May 2013
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

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。

AstraZeneca Announces Results of Recentin HORIZON II Phase III Trial in Metastatic Colorectal Cancer
Friday, 28 May 2010

AstraZeneca 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).

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.

Based on the results of these two trials, AstraZeneca does not intend to file regulatory submissions in first-line mCRC.

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.

Data from HORIZON II and HORIZON III will be submitted to a forthcoming medical congress.

上述是来自阿斯利康官方网站上的公告。

1548588601 · 发表于 2014-5-7 09:10:28

是阿瓦的升级品吧

行者老金 · 发表于 2014-5-9 22:42:36

1548588601 发表于 2014-5-7 09:10
8 |% v7 N+ x6 t+ |7 {: I0 s) t是阿瓦的升级品吧

抱歉，对靶向药研究不多，不太清楚

υīСКī · 发表于 2014-5-12 14:05:25

http://www.clinicaltrials.gov/ct ... rm=MCRC&rank=27
临床进行到I II期，有空我会翻译下，或者大家可以求助一下前沿版块的COSTA翻译

行者老金 · 发表于 2014-5-12 18:46:35

υīСКī 发表于 2014-5-12 14:05) C$ F6 J5 \# @3 C0 f F6 A1 k
http://www.clinicaltrials.gov/ct2/show/study/NCT00494221?term=MCRC&rank=27
% Q6 c6 R8 p$ e0 Z临床进行到I II期，有空我 ...

谢谢！