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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00083525
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : January 24, 2008
Sponsor:
Collaborator:
United States Department of Defense
Information provided by:
Wilex

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: WX-UK1 in combination with Capecitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2004

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083525


Locations
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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Wilex
United States Department of Defense
More Information
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ClinicalTrials.gov Identifier: NCT00083525    
Other Study ID Numbers: WX/50-005
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: January 24, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Neoplasms
Capecitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents