Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg Pharma AG; Wilex
• Collaborator: United States Department of Defense
• Treatments: Capecitabine

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