CHS 828 in Treating Patients With Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003979|
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : July 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: CHS 828||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|