新药西地尼布Cediranib（AZD2171），医科院肿瘤医院一期试验对肺癌有效

西地尼布(Recentin)由阿斯利康公司开发，其主要抑制VEGFR-1、VEGFR-2、VEGFR-3和PDGFR。本品口服可使再发性恶性胶质瘤患者的肿瘤血管恢复正常。它起效迅速，作用时间长，且具有可逆性，还可显著减轻水肿。Laurie等报道20例卡铂
(AUC为6)+紫杉醇(200mg／m2 )联合本品治疗初治的Ⅲ B和Ⅳ 期NSCLC的研究结果，9例本品剂量为30 mg，11例本品剂量为45
mg，15例可评估患者中6例获得部分缓解(PR)，8例疾病稳定，1例疾病进展。较常见的Ⅱ度以上剂量依赖性不良反应是肝功能异常、高血压、粒细胞下降和黏膜炎，其他常见不良反应是乏力、厌食、腹泻等。本品联合吉非替尼的研究正在进行。目前，本品的脑癌和CRC适应证开发处于Ⅲ
期临床研究阶段，NSCLC、RCC、GIST等适应证处于Ⅱ期临床研究阶段。


只有联合的，单药还没找到数据，希望大家能提供一下

痛恨癌症 发表于 2011-3-30 12:54

                               
登录/注册后可看大图

今天问诊韩宝惠提到西地尼布了，韩医生第一反应就是“你能弄到药么？”

然后就说目前数据太少，国内1期算 ...

我在医科院肿瘤医院问诊的情况也差不多。大夫说，根据他试验的情况看，这是个好药，对肺癌很有效。接着就说，问题是这个药买不到。我追问他试验的具体情况，他不肯多讲，叫我不要在这个药上费功夫。这几天在找肺癌脑转的试验，也没找到什么有价值的信息。看来希望还是渺茫

yezi 发表于 2011-3-30 14:34

                               
登录/注册后可看大图

我在医科院肿瘤医院问诊的情况也差不多。大夫说，根据他试验的情况看，这是个好药，对肺癌很有效。接着就 ...

如果只是这样纸上谈兵，如果只是等待试验报告出来，如果只是等待药品在中国大陆上市，如果只是等待医生认可，那么就只能仅吃易、特、索拉、索坦。有一点点关于正在进行临床试验的信息，有一点点有效的信息，就可以寻找药品，买回来就吃。人们曾经吃和正在吃的BIBW2992、凡德他尼、阿西替尼、依维莫司、CA4P……以及前年就用上的阿瓦斯汀，有哪样是正式试验报告面世、药品正式在中国大陆上市和医生主张、赞同或建议的？
与期等待，不如寻找；与期询问医生，不如把药吃进肚里。

憨豆精神 发表于 2011-3-30 15:21

                               
登录/注册后可看大图

如果只是这样纸上谈兵，如果只是等待试验报告出来，如果只是等待药品在中国大陆上市，如果只是等待医生认 ...

憨叔批评得很对，平安也表达了这个意见，以前也有别的病友批评我这种迟疑不决的性格。我左右犹豫的原因主要还是自己对这个药了解不够，而我妈妈体质又比较弱，尤其是看到平安上面说的副作用有一条是腹绞痛和消瘦，更加重了担心。打算抓紧再了解些信息，同时看特＋替的效果，不行再试试别的靶向药＋替，万一再不行只好试试这个药了。

平安！ 发表于 2011-3-29 11:20

                               
登录/注册后可看大图

临床试验用药病人反映副作用没有索坦厉害，但消化道反应很明显：腹绞痛，腹泻。继之而来的体重减轻。病人形 ...

你只关注我那句话的后半截，前面“没有索坦厉害”你倒不关注了。索坦我们这论坛的绝大多数病人都能耐受，比索坦还好就是比较温和的药了。腹绞痛是突然发作的急性痛，倒是好处理一些。何况任何靶向药的副作用都是因人而异，不是每个人都一定会发生。我把国外个别服药病人的副作用写上主要是怕有人吃如果出现这种急诊好心里有数。

其实我个人觉得，副作用能耐受的话，不会致命，如果肿瘤控制不好就危险了，强烈关注此药，希望大家有更多的途径能买到

我看中国一期临床给的是每天20mg和30mg，所以如果大家试用或许可以从20mg开始，慢慢增加，因为国外2期30mg有部分人群已经无法耐受了,尽管1期45mg都可以耐受

痛恨癌症 发表于 2011-3-30 19:59

                               
登录/注册后可看大图

我看中国一期临床给的是每天20mg和30mg，所以如果大家试用或许可以从20mg开始，慢慢增加，因为国外2期30mg有 ...

应该倒过来，先足量，不行才中途停药，再不行才减量。
从小量开始的吃法，前面的就成了白吃，浓度太低。

昨天在痛恨癌症的帖子里看到，一个美国的肿瘤医生说西地尼布的非小细胞肺癌试验终止了http://www.yuaigongwu.com/forum.php?mod=viewthread&tid=640&extra=page%3D1。这几天我也在搜西地尼布的信息，查到在加拿大、日本的非小试验被终止，但这个信息是2007－2008年的，查不到更近一些的信息了。不知是不是其他国家的非小试验也被终止了？如果非小的试验被全面终止了，那么西地尼布对于非小脑转移是不是仍然有效呢？请平安、痛恨癌症等高手们指点，非常感谢！

2008年2月，阿斯利康公司宣布，加拿大国立癌症研究所牵头的BR.24研究被中止。这是一项Ⅱ/Ⅲ期的临床试验，评价卡铂和紫杉醇联合或不联合AZD2171作为NSCLC的一线治疗。这项临床研究在中期分析后被终止，也不会进行Ⅲ期试验。其初步结果显示AZD2171组的毒性不平衡。
http://www.astrazeneca.com/Media ... ENTIN-Clinical-Deve
•        AstraZeneca provides update on cediranib (RECENTIN™, AZD2171) clinical development programme
HORIZON colorectal cancer programme continues into Phase III; BR24 non-small cell lung cancer trial will not progress
February 27, 2008 - AstraZeneca today announced that its HORIZON III Phase II/III head-to-head study of cediranib (RECENTIN™, AZD2171) with chemotherapy versus bevacizumab (Avastin™) with chemotherapy in patients with first line metastatic colorectal cancer (CRC) will be progressing directly into Phase III at 20mg.  Patients will also continue to be recruited at 20mg into the first line CRC HORIZON II study of cediranib with chemotherapy versus chemotherapy alone.
The HORIZON Independent Data Monitoring Committee (IDMC) conducted a planned end of Phase II (EOP II) review of efficacy and tolerability data from HORIZON I, HORIZON II and HORIZON III. Data from HORIZON I, in second line colorectal cancer, would not by itself have contributed to a positive EOP II decision. However, when combined with a review of data from HORIZON II and III by the IDMC, the IDMC confirmed the HORIZON programme in 1st line CRC could continue and HORIZON II and III had met pre-defined EOP II criteria.
AstraZeneca today also announced that the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study’s Data Safety Monitoring Committee.  Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III.
AstraZeneca is working in close collaboration with the NCIC-CTG to understand the BR24 data further.  
In addition to colorectal and non-small cell lung cancer, the cediranib development programme includes trials in recurrent glioblastoma and a number of signal search studies in other tumours.
John Patterson, AstraZeneca’s Executive Director for Development, said: “Given there is such a high unmet patient need for more effective treatments in cancer, we are pleased that the HORIZON colorectal cancer programme has met its pre-defined criteria to continue recruitment into Phase III. Due to the Phase II/III trial design, HORIZON III is able to move directly into Phase III utilising all the Phase II data and this saves valuable time in assessing the potential benefit of cediranib in the first line metastatic colorectal cancer setting.”
“AstraZeneca supports the NCIC-CTG’s BR24 recommendation and is working with them to understand the data more fully in NSCLC. As evidence of clinical activity was seen in BR24, AstraZenenca remains committed to investigating the potential of cediranib in lung cancer and reducing the incidence of serious adverse events.”
RECENTIN™ is a trademark of the AstraZeneca group of companies.
– ends –



2007年10月开展的日本非小细胞肺癌I/II期试验也中止了http://clinicaltrials.gov/ct2/show/NCT00539331?term=Phase+I%2FII+Study+of+AZD2171+in+Combination+With+Paclitaxel%2FCarboplatin+in+Japanese+Non-Small+Cell+Lung+Cancer+Patients&rank=1

Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients
This study has been terminated.
Study NCT00539331   Information provided by AstraZeneca
First Received: October 2, 2007   Last Updated: December 7, 2010   History of Changes

No Study Results Posted on ClinicalTrials.gov for this Study
About Study Results Reporting on ClinicalTrials.gov
  Study Status:         This study has been terminated.
  Study Completion Date:         September 2008
  Primary Completion Date:         September 2008 (Final data collection date for primary outcome measure)



下面这个试验肺癌病人入组于8/9/07关闭
http://clinicaltrials.gov/ct2/sh ... %2F9%2F07%29&rank=1

AZD2171 and Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer, Colorectal Cancer, or Other Cancer Suitable for Treatment With Capecitabine (Non-Small Lung Cancer Patients Closed to Enrollment as 8/9/07)
This study has been completed.

First Received on April 5, 2005.   Last Updated on January 18, 2011   History of Changes
Sponsor:         NCIC Clinical Trials Group
Information provided by:         NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:         NCT00107250