Full Text View
Tabular View
No Study Results Posted
Related Studies
Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies
This study has been completed.

First Received on May 25, 2004.   Last Updated on January 21, 2008   History of Changes
Sponsor: Wilex
Collaborator: Department of Defense
Information provided by: Wilex
ClinicalTrials.gov Identifier: NCT00083525
  Purpose

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 Intervention Phase
Advanced Malignancies
Drug: WX-UK1 in combination with Capecitabine
Phase I

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Wilex:

Estimated Enrollment: 33
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083525

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Wilex
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00083525     History of Changes
Other Study ID Numbers: WX/50-005
Study First Received: May 25, 2004
Last Updated: January 21, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012