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Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer Clinical research trials and Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer. Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer  Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer
Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer
For Condition: Carcinoma, Non-Small Cell Lung,Non-Small-Cell Lung Carcinoma
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens. The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. Secondary objectives include: - To further evaluate the safety of EKB-569 - To explore additional clinical activity parameters - To explore subject survival - To evaluate the pharmacokinetics of EKB-569 - To assess subject reported outcomes EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures. - Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy. - Progression (or unacceptable toxicity) after platinum- (e.g., carboplatin or cisplatin) and docetaxel-based chemotherapy, either given concurrently (1 regimen) or as separate treatments (adjuvant or neo-adjuvant chemotherapy does not count as prior chemotherapy treatment). - Measurable disease defined by the presence of at least 1 measurable lesion 20 mm by conventional techniques, or 10 mm by spiral computed tomography (CT) scan, or 2 x slice thickness. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (not declining within the past 2 weeks). - Age 18 years or older. - Recovery from all acute adverse effects of prior therapies (excluding alopecia). - Adequate renal, hepatic and bone marrow function - For women of childbearing potential, a negative serum pregnancy test at screening. - Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use medically acceptable methods of birth control (eg, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) for the duration of the active phase of the study, and for 30 days after the last dose of test article. Exclusion Criteria: - Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas). - Prior radiotherapy to >25% of bone marrow. - Prior epidermal growth factor receptor-targeting therapy. - Use of immunosuppressive agents, including systemic corticosteroids, within 4 weeks of screening (corticosteroids are permitted in physiological replacement doses and as symptomatic episodic treatment of nausea). - Central nervous system (CNS) metastases. - Major surgery within 2 weeks of screening. - Concurrent serious infection (ie requiring an intravenous antibiotic or antiviral agent). - Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn’s disease, ulcerative colitis, malabsorption syndrome, Grade 2 diarrhea of any etiology at baseline). - Inability to swallow the EKB-569 capsule. - Breastfeeding of infants during the study or within 30 days after the last dose of test article. - Evidence of significant skin disorder with symptomatic rash.
Total Enrollment:
Location and Contact Information:
University of Colorado *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Karen Kelly 720-848-0676
Jacksonville Regional Cancer Center *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Neil Abramson 904-202-7051
Swedish Cancer Institute/PSOC *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Howard West 206-386-2424
Florida Cancer Institute Clinical Research *Recruiting*
New Port Richey, Florida, 34452
United States
Recruiting Gerald Robbins 727-843-9841
John Wayne Cancer Institute *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Peter Boasberg 310-998-3973
Oschner Clinic Foundation *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting John Cole 504-842-3910
Medical College of Georgia *Recruiting*
Augusta, Georgia, 30912
United States
Recruiting Andre Kallab 706-721-2505
Medical Consultants, LTD *Recruiting*
Milwaukee, Wisconsin, 53215
United States
Recruiting Jonathan Treisman 414-649-5605
Henry Ford Health Center/Josephine Ford Cancer Center *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-7277
WJB Dorn VA Medical Center *Recruiting*
Columbia, South Carolina, 29209
United States
Recruiting William Hrushesky 803-776-4000
University of Kansas *Recruiting*
Kansas City, Kansas,
United States
Recruiting Steve Williamson 913-588-6029
North Mississipi Hematology and Oncology Associates, Ltd. *Recruiting*
Tupelo, Mississippi, 38801
United States
Recruiting Christopher Croot 662-844-9166
Ocala Oncology *Recruiting*
Ocala, Florida, 34474
United States
Recruiting Maury Berger 352-732-4032
Medical College of Wisconsin *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Paul Ritch 414-805-6837
Midwestern Regional Medical Center *Recruiting*
Zion, Illinois, 60099
United States
Recruiting Joel Granick 847-731-4143
Charleston Cancer Center *Recruiting*
Charleston, South Carolina, 29406
United States
Recruiting Charles Graham 843-572-9211
Greater Baltimore Medical Center *Recruiting*
Baltimore, Maryland, 21204
United States
Recruiting Gary Cohen 443-849-8058
Additional Information:
Study ID Numbers: 3095A1-201-WW;
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067548
Other Non-Small-Cell Lung Carcinoma Studies:
1. A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer
Related Studies:
Other Non-Small-Cell Lung Carcinoma Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials
Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer
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