Status:
COMPLETED
Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies
Lead Sponsor:
Heidelberg Pharma AG
Collaborating Sponsors:
United States Department of Defense
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00083525
Start Date
May 1 2004
Last Update
January 24 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111