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A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer. Clinical research trials and A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer. health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer.. A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer. Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer. clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer. condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer.  A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer.
A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer.
For Condition: Colorectal Cancer
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 colorectal cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or capecitabine) and either oxaliplatin or irinotecan (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 colorectal 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. - Previous histologic diagnosis of adenocarcinoma of the colon or rectum. - EGFR expression by immunohistochemical analysis (must be > or = 20% positive tumor cells in prior tumor biopsy specimens). - Must have received prior treatment with a fluoropyrimidine (5-FU or capecitabine), and either oxaliplatin or irinotecan (in separate or concurrent regimens). - Recurrent or progressive disease for which no potentially curative therapy is available. - 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 2x 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. - Life expectancy of at least 12 weeks. - 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 epidermal growth factor receptor-targeting therapy. - Known central nervous system (CNS) metastases. - 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). - 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:
Henry Ford Health Center *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Ira Wollner 313-876-7277
Cancer Institute Medical Group *Recruiting*
Los Angeles, California, 90025
United States
Recruiting Rosen Lee 310-231-2124
Georgia Cancer Specialists - Kennestone *Recruiting*
Marietta, Georgia, 30060
United States
Recruiting Mansoor Saleh 770-590-8311
Georgia Cancer Spec.-Stemmer *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Mansoor Saleh 770-908-5160
WJB Dorn VA Medical Center *Recruiting*
Columbia, South Carolina, 29209
United States
Recruiting Maria Delioukina 803-776-4000
Georgia Cancer Specialists *Recruiting*
Atlanta, Georgia, 30042
United States
Recruiting Mansoor Saleh 770-496-9403
Medical Consultants, LTD *Recruiting*
Milwaukee, Wisconsin, 53215
United States
Recruiting Jonathan Treisman 414-649-6093
Oschner Clinic Foundation *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting David Oubre 504-842-3910
Georgia Cancer Specialists - Macon *Recruiting*
Macon, Georgia, 31217
United States
Recruiting Mansoor Saleh 478-745-6130
Midwestern Regional Medical Center *Recruiting*
Zion, Illinois, 60099
United States
Recruiting Joel Granick 847-872-6179
MD Anderson Cancer Center Orlando *Recruiting*
Orlando, Florida, 32806-2032
United States
Recruiting Omar Kayaleh 321-841-1859
Lombardi Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting John Marshall 202-687-6653
Additional Information:
Study ID Numbers: 3095A1-200-WW;
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072748
Other Colorectal Cancer Studies:
1. Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
2. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
3. Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
4. Phase III Study of Irinotecan and Cetuximab vs Irinotecan as Second-Line Treatment in Patients with Metastatic, EGFR-Positive Colorectal Cancer
5. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
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A Phase 2 Study of Single Agent EKB-569 in Subjects with Advanced Colorectal Cancer.
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