Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies
Phase 1
Completed
- Conditions
- Advanced Malignancies
- Registration Number
- NCT00083525
- Lead Sponsor
- Heidelberg Pharma AG
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States