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发表于 2009-4-5 21:34:30
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来自: 中国江苏南京
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.
Condition Intervention Phase
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 |
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