NCT00083525

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2004

Completed
Last Updated

January 24, 2008

Status Verified

January 1, 2008

First QC Date

May 25, 2004

Last Update Submit

January 21, 2008

Conditions

Advanced Malignancies

Interventions

WX-UK1 in combination with CapecitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

N-alpha-(2,4,6-triisopropyl-phenylsulfonyl)-3-amidino-(L)-phenyl-alanine-4-ethoxycarbonyl-piperazide hydrochlorideCapecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 25, 2004

First Posted

May 26, 2004

Study Start

May 1, 2004

Last Updated

January 24, 2008

Record last verified: 2008-01

Locations

US(1)