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.

Condition	Treatment or Intervention	Phase
Advanced malignancies	Drug: WX-UK1 in combination with Capecitabine	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting

Study ID Numbers:  WX/50-005
Record last reviewed:  May 2004
Record first received:  May 25, 2004
ClinicalTrials.gov Identifier:  NCT00083525
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09