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

January 21, 2008 updated by: Heidelberg Pharma AG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg Pharma AG

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

May 25, 2004

First Submitted That Met QC Criteria

May 25, 2004

First Posted (Estimate)

May 26, 2004

Study Record Updates

Last Update Posted (Estimate)

January 24, 2008

Last Update Submitted That Met QC Criteria

January 21, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WX/50-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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