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

Advanced Malignancies Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083525
• Other study ID #: WX/50-005
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2004
• Last updated: January 21, 2008
• Start date: May 2004

Study information

• Verified date: January 2008
• Source: Wilex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Drug:
• WX-UK1 in combination with Capecitabine

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wilex	United States Department of Defense

Country where clinical trial is conducted

United States,