CHS 828 in Treating Patients With Solid Tumors
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks|
|Study Start Date:||April 1999|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003979
|Innsbruck, Austria, A-6020|
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Institut Jules Bordet|
|Brussels, Belgium, B-1000|
|Ludwig Institute for Cancer Research|
|Brussels, Belgium, B-1200|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Herlev Hospital - University Hospital of Copenhagen|
|Copenhagen, Denmark, DK-2730|
|Bordeaux, France, 33076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Leon Berard|
|Lyon, France, 69373|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Universitaetsklinik und Strahlenklinik - Essen|
|Essen, Germany, D-45122|
|Klinikum Nuernberg - Klinikum Nord|
|Nuremberg, Germany, 90340|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1001HV|
|Antoni van Leeuwenhoekhuis|
|Amsterdam, Netherlands, 1066 CX|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9700 RB|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3075 EA|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|C.R.C. Beatson Laboratories|
|Glasgow, Scotland, United Kingdom, G61 1BD|
|Study Chair:||Thomas Cerny, MD||Cantonal Hospital of St. Gallen|