CHS 828 in Treating Patients With Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00003979
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Determine a safe dose of this regimen for phase II evaluation.
* Determine the pharmacokinetic profile of this regimen in these patients.
* Determine any antitumor activity in these patients.
OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed for up to 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Ludwig Institute for Cancer Research
🇧🇪Brussels, Belgium
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
University Hospital
🇨ðŸ‡Basel, Switzerland
Institut Jules Bordet
🇧🇪Brussels, Belgium
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
C.R.C. Beatson Laboratories
🇬🇧Glasgow, Scotland, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Copenhagen, Denmark
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Institut Gustave Roussy
🇫🇷Villejuif, France
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Institut Bergonie
🇫🇷Bordeaux, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Centre Leon Berard
🇫🇷Lyon, France
Universitaetsklinik und Strahlenklinik - Essen
🇩🇪Essen, Germany
Institut Claudius Regaud
🇫🇷Toulouse, France
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuremberg, Germany
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom