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Philadelphia, Pennsylvania 19111


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.


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



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Philadelphia, Pennsylvania 19111
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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