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Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma Clinical research trials and Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma. Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma  Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma
Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma
For Condition: Lymphoma, Malignant,Neoplasms
Status: Recruiting
Sponsor(s): Eisai Medical Research Inc ,
Synopsis: The purpose of this study is to determine the appropriate dose of E7820 and to evaluate its safety.
Details: Angiogenesis, the process of new blood vessel formation and growth, is involved in both physiological and pathological processes. Following a hypothesis that tumor growth and progression is dependent upon continuous blood supply and neovascularization via angiogenesis, the search for an effective drug that would inhibit this process and prevent further progression of the tumor has led to the development of various agents for chemotherapeutic purpose. E7820 has demonstrated anti-angiogenesis activity based on inhibition of endothelial cell proliferation and tube formation. The purpose of this study is to evaluate the safety of E7820 and to determine an appropriate dose for future investigations.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must have a histologically or cytologically confirmed malignant solid tumor or lymphoma. Malignancy must be advanced and require systemic therapy. Malignancy must be one for which no standard therapy is available or the patient must not be a candidate for standard therapy. - Patients must have a Karnofsky Performance Status of >= 70%, - Patients must have a life expectancy of >= 3 months, - Patients must be aged >= 18 years, - Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/minute/1.73m2, - Patients must have adequate bone marrow function as evidenced by ANC >= 1,500 mm3 and platelets >= 100,000 mm3, - must have adequate liver function as evidenced by bilirubin <= 1.5 mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2.5 times the upper limits of normal (ULN) (unless related to liver metastases in which case <= 5 x ULN), - Patients must be willing and able to comply with the study protocol for the duration of the study, and - Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice. Exclusion Criteria: - Patients who have a history of previous hypersensitivity to sulfonamide derivatives, - Patients who have received chemotherapy within 4 weeks (6 weeks if nitrosoureas were received) of commencing study treatment, - Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic radiation) within 4 weeks of E7820 treatment, - Patients who have not recovered from any clinically significant chemotherapy or radiotherapy related toxicity at study entry. - Patients who have received investigational drugs or other antineoplastic therapy within 28 days of E7820 treatment, - Patients who have had major surgery within 4 weeks of study drug administration, - Women who are pregnant or breast-feeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential), - Fertile men and fertile women who are not willing to use contraception or fertile men or fertile women with a partner who is not willing to use contraception, - Patients with active central nervous system (CNS) metastases (i.e., evidence of progressive clinical symptoms, edema requiring corticosteroids, or tumors exhibiting growth on sequential MRI or CT scans), - Patients who are known to be positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus, - Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies), - Patients with a history of unstable ischemic disease, - Patients with a history of clinically significant thrombosis, - Patients receiving antithrombotic (including aspirin) or therapeutic anticoagulant therapy (prior to study entry, patients receiving these types of drugs must have been off therapy for at least 7 days), - Patients with a history of documented vascular headache with neurological changes, - Patients < 30% of ideal weight for height and age according to the Metropolitan Life Insurance Company Statistical Bulletin, or - Patients with significant disease, or any condition, which in the Investigator’s opinion would exclude the patient from the study.
Total Enrollment: 24
Location and Contact Information:
Additional Information:
Study ID Numbers: E7820-A001-102;
Study Start Date: January 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078637
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1. Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma
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Dosing and Safety Study of E7820 in Patients with a Malignant Solid Tumor or Lymphoma
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