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

Heidelberg Pharma

Status and phase

Completed

Phase 1

Conditions

Advanced Malignancies

Treatments

Drug: WX-UK1 in combination with Capecitabine

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT00083525

WX/50-005

Details and patient eligibility

About

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.

Enrollment

33 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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