Completed

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

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What is being tested

Data Collection

Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorHeidelberg Pharma AG
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleUrokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies 
NCT00083525
Principal SponsorHeidelberg Pharma AG
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
33 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasms
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Fox Chase Cancer CenterPhiladelphia, United StatesSee the location

CompletedOne Study Center
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