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Phase 1
18 Years
Not Enrolling
Advanced Malignancies

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Trial Information

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

  • Advanced Malignancies
  • Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111