|
Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies Clinical research trials and Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies. Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies clinical trial. Subjects typically recieve the finest healthcare available for their Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "U" Clinical Trials Conditions > Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies  Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies
Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies
For Condition: Advanced malignancies
Status: Recruiting
Sponsor(s): Wilex , US Department of Defense
Synopsis: The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine in patients with advanced malignancies.
Details:
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: - Histologically or cytologically confirmed diagnosis of a non-hematologic malignancy that is either unresponsive to currently available therapies or for which there is no known effective therapy. - Patient willing to give informed consent, understand and comply with study procedures/restrictions - Age>=18 - Patients must have an ECOG performance status of 0, 1, or 2 - Life expectancy of > 12 weeks - Negative serum pregnancy test for women of child-bearing potential and not nursing. Fertile patients must use effective contraception during and for 30 days (women) or 4 months (men) after treatment with WX-UK1. - Measurable or non-measurable disease. Patients without clinical or radiologic evidence of disease are not eligible. - Laboratory parameters (obtained within the screening period): WBC >= 3 G/L, neutrophils >= 1.5 G/L, platelets >= 100 G/L, Hgb >= 9 g/dL), total bilirubin <= 1.5 x ULN, ASAT/ALAT/AP/GGT <= 2.5 x ULN, serum creatinine <= 2 x ULN. Exclusion Criteria: - History of hypersensitivity to the study drugs or chemically related compounds or any of the excipients - History of or current neurological disorder, in particular an active or treated seizure disorder - Known standard therapy for the patient’s disease that is potentially curative or known to extend life expectancy. - Carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease. - Concurrent or prior (within 4 weeks prior to start of WX-UK1 treatment for cytotoxic chemotherapy, biological-, endocrine-, investigational- or radiotherapy and 6 weeks for nitrosoureas, mitomycin-C) - Uncontrolled infection - Significant cardiac disease (NYHA classification III or IV - Contraindication to an infusion volume of 1000 ml over 2 h - History of or current blood coagulation disorders - History of or current bleeding disorder (including cerebral bleeding, recurrent massive nose bleeds, hematuria or unexplained bruising) - Diabetes mellitus, if not controlled by insulin, oral anti-diabetic agents or diet alone - Anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except heparin flush to keep a port open or coumadin 1 mg/day or ASA 100mg/d) - Active serious illness that renders the patient unsuitable for study entry or multiple blood sampling - Illness or condition that might alter the absorption, distribution, metabolism and elimination of WX-UK1 - Known Hepatitis B/C or HIV infection - Contraindication to capecitabine intake as specified in the SPC such as DPD-deficiency or concomitant intake of sorivudine or sorivudine related compounds - Known hemorrhagic brain metastasis
Total Enrollment: 33
Location and Contact Information:
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Lori Goldstein 215-728-2191
Additional Information:
Study ID Numbers: WX/50-005;
Study Start Date: May 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083525
Other Advanced Malignancies Studies:
1. Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies
Related Studies:
Other Advanced malignancies Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Urokinase-plasminogen activator (uPA) inhibitor WX-UK1 in combination with Capecitabine in Advanced Malignancies
|
|
|
|
|
|
|
|
