如何找到临床试验
很多病友希望能够注册到临床实验中去，我推荐一点我自己搜索信息的方法：１）如果你听说某个药品的效果很好，打算试图找个有试验的医院，比如这里ＢＩＢＷ ２９９２
２）可以在http://www.clinicaltrials.gov/搜索这个关键字
３）你可以看到下列信息（拷屏方便，不全）
Rank Status Study
1 RecruitingTrial Exploring BIBW 2992 + Paclitaxel (Part A) and BIBW 2992 + Paclitaxel + Bevacizumab (Part B) in Patients With Advanced Solid Tumours Condition:Neoplasms
Interventions:Drug: BIBW 2992; Drug: Paclitaxel; Drug: Bevacizumab
2 CompletedA Multi-Centre 3-Arm Randomised Phase II Trial of BIBF 1120 Versus BIBW 2992 Versus Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Hormone-Resistant Prostate Cancer Condition:Prostatic Neoplasms
Interventions:Drug: BIBF 1120; Drug: BIBW 2992; Drug: Sequential BIBF 1120 + BIBW 2992
3 RecruitingStudy to Determine the Maximum Tolerated Dose of BIBW 2992 When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours Condition:Neoplasms
Intervention:Drug: BIBW 2992
4 Active, not recruitingPhase I of BIBW 2992/BIBF 1120 Combination Therapy in Solid Tumors Condition:Neoplasms
Interventions:Drug: BIBW 2992; Drug: BIBF 1120
5 RecruitingBIBW 2992 QTcF Trial in Patients With Relapsed or Refractory Solid Tumours Condition:Neoplasms
Intervention:Drug: BIBW 2992
其中ｒｅｃｒｕｉｔｉｎｇ表示在找患者，ｃｏｍｐｌｅｔｅｄ表示已完成，这里你可以看到更真实的实验数据而不是报纸上耸动的标题
４）进入具体页面看看试验的具体内容。比如同是ｂｉｂｗ２９９２的实验，与安慰剂对比的对患者风险更大，因为你有５０％的可能吃到安慰剂，但是同时进行的种族间对比就安全很多，至少每个人都吃的是药品
５）如果你看了入组条件和试验内容，你都觉得比较满意，就可以在下面找试验地点，多中心的实验最有可能ｃｏｖｅｒ到中国啦，看看你能去的城市有没有．．
６）如果你找到了中国／你所在的城市（有时候网站不公布具体地点，给的是代码），那么你有俩办法：如果你可以用英文描述清楚你的ｓｉｔｕａｔｉｏｎ，就写信给报名的ｅｍａｉｌ．如果英文不太好，那么简单的办法是：查找药厂的中文网页
７）试试吧，你会发现其实药厂的免费电话还不错呢，可能比医院的医生态度要好呢～他们一般会告诉你联系人电话之类的信息。
希望对找试验的病友有帮助 另外，提醒一下，好好阅读入组条件还是挺重要的－－每个试验的要求都不少，否则白白耽误你自己的时间不说，还潜在的风险耽误了病人的病情啊。
回复 2# passion 的帖子
感谢分享！ 感谢passion提供的信息，对我很有帮助，谢谢~！ 感谢passion提供的信息，但愿能帮到有需要的病友！谢谢LZ
BIBW 2992 and BSC Versus Placebo and BSC in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, March 2009
First Received: April 4, 2008 Last Updated: March 4, 2009 History of Changes
Sponsored by:Boehringer Ingelheim Pharmaceuticals
Information provided by:Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:NCT00656136
Purpose
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed. The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.
Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety, and PK profile of BIBW 2992 as well as on the health-related quality of life.
ConditionInterventionPhase
Carcinoma, Non-Small-Cell Lung
Drug: BIBW 2992
Phase III
MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib BIBW 2992
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase IIb/III Randomized, Double-Blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
Overall survival time (OS) [ Time Frame: 9 months ]
Secondary Outcome Measures:
PFS, ORR, Duration of clinical benefit. . Time to ORR. Duration of ORR. Safety and PK of BIBW 2992. HRQOL. [ Time Frame: 7 months ]
Estimated Enrollment: 400
Study Start Date: April 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as >20 mm using conventional techniques or >10 mm with spiral CT scan
Male and female patients age >18 years
Life expectancy of at least three (3) months
Written informed consent that is consistent with ICH-GCP guidelines
Exclusion Criteria:
Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
Active brain metastases
Significant or recent acute gastrointestinal disorders with diarrhea
Patients who have any other life-threatening illness or organ system dysfunction,
Other malignancies diagnosed within the past five (5) years
Radiotherapy within the past 2 weeks prior to treatment
History of clinically significant or uncontrolled cardiac disease
Adequate ANC and platelet count
Adequate liver and kidney function
Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656136
Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Hide Study Locations
Locations
China
1200.23.86001 Boehringer Ingelheim Investigational Site Recruiting
Beijing, China
1200.23.86002 Boehringer Ingelheim Investigational Site Recruiting
Beijing, China
1200.23.86007 Boehringer Ingelheim Investigational Site Recruiting
Guangzhou, China
1200.23.86004 Boehringer Ingelheim Investigational Site Recruiting
Shanghai, China
1200.23.86005 Boehringer Ingelheim Investigational Site Not yet recruiting
Shanghai, China
1200.23.86006 Boehringer Ingelheim Investigational Site Not yet recruiting
Shanghai, China
1200.23.86003 Boehringer Ingelheim Investigational Site Recruiting
Beijing, China
Hong Kong
1200.23.85202 Boehringer Ingelheim Investigational Site Recruiting
Hong Kong, Hong Kong
Taiwan
1200.23.88601 National Taiwan University Hospital Recruiting
Taipei, Taiwan
1200.23.88602 Veterans General Hospital Recruiting
Taipei, Taiwan
1200.23.88603 Chang Gung Memorial Hosp-Linkou Recruiting
Taoyuan, Taiwan
1200.23.88604 Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
1200.23.88605 China Medical University Hospital Recruiting
Taichung, Taiwan
1200.23.88606 National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
1200.23.88607 Tri-Service General Hospital Recruiting
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
More Information
No publications provided
Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1200.23
Study First Received: April 4, 2008
Last Updated: March 4, 2009
ClinicalTrials.gov Identifier: NCT00656136 History of Changes
Health Authority: Belgium: Federal Agency for Medicines and Health Products; China: State Food and Drug Administration; France: AFFSAPS; Germany: Ministry of Health; Great Britain: MHRA; Hong Kong: Department of Health; Italy: Comitato Etico Azienda USL 4 - PRATO; Korea, Republic of: Korea Food and Drug Administration; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Singapore: Health Sciences Authority, Ministry of Health; Spain: Spanish Agency for Medicines and Health Products; Taiwan: Department of Health, Executive Yuan, Taiwan; Thailand: Ministry of Public Health; United States: Food and Drug Administration
Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma
Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma
ClinicalTrials.gov processed this record on April 03, 2009
回复 6# gexiaom 的帖子
我们这是一个公益性的网站,其宗旨是为广大患者服务的,对于用外语发帖来说,可能大多数朋友很难看懂,即或是有4级的水平,看起来也很费力,况且其中还有不少的专业术语,其帖的服务对象必然受到了一定的局限性,所以诚肯地希望这些朋友能把它翻译成中文发表,对于个别无法翻译的专业术语除外,当然也可按你的理解作出一定的解释更好.对不起,谢谢你了!
由于术语太多,试译了一段如下:
BIBW 2992和在出故障Erlotinib或Gefitinib (LUX-LUNG 1)的非小细胞肺癌患者的BSC对安慰剂和BSC
这项研究当前吸收参加者。核实由Boehringer Ingelheim配药， 2009年3月
首先接受： 2008年4月4日 最近更新： 2009年3月4日 变动的历史
Sponsored ： Boehringer Ingelheim配药
信息提供了： Boehringer Ingelheim配药
ClinicalTrials.gov标识符： NCT00656136
目的被随机化的这，双盲，多中心阶段IIb/III试验在患者将执行与接受了与至少一个的早先治疗的NSCLC，但是不超过细胞毒素的化疗二条线(一条线一定是白金包含的养生之道)和gefitinib或erlotinib至少12个星期的期间然后进步。 这个随机比对临床试验主要宗旨将确定效力BIBW 2992作为一个唯一代理(与配比的安慰剂(在这患者人数的胳膊B)比较的胳膊A)。 除研究治疗之外，两条治疗胳膊的患者将得到最佳的支援关心。患者注册入试验将治疗并且被跟随直到死亡或失去对后续。 其它信息在安全和PK外形将得到在与健康有关的生活水平的BIBW 2992并且。
情况干预阶段
Carcinoma，非小细胞肺
Drug ： BIBW 2992
Phase III
MedlinePlus关系了题目： 巨蟹星座肺癌
Drug有用的资料为： Erlotinib BIBW 2992
U.S. 粮食与药物管理局资源
Study类型： Interventional
研究设计： 治疗，平行的任务、安全或者效力研究
Official标题： IIb/III被随机化的阶段，双盲试验BIBW 2992正最佳的支援关心(BSC)对安慰剂加上在非小细胞肺癌患者的BSC
出故障的Erlotinib或Gefitinib
实属难以看懂.
[ 本帖最后由 clf6019 于 2009-4-13 12:57 编辑 ] 正如楼上所说这些英语对于病友来说实在太过困难!比较便捷的方法是到离你最近的省会城市的大医院的肿瘤科或者呼吸科去打听,通常一个临床研究都会在每个参加的医院指定一个负责医生,而门诊的医生都会协助他招募病人.所以挂个普通门诊问下医生就可以了.
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