本帖最后由 yezi 于 2011-4-7 09:38 编辑
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.
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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
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