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
CHS 828
Treatment Study
Summary
Study start date: April 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor not amenable to standard therapy No symptomatic brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 1.5 mg/dL Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases) Renal: Creatinine no greater than 1.4 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No active bacterial infection No other nonmalignant disease No alcoholism, drug addiction, or psychiatric disorders Able to take oral medication PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy) No concurrent radiotherapy (except palliative radiotherapy) Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent antitumor drugs
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 28 locations
Kaiser Franz Josef Hospital
Vienna, AustriaInstitut Jules Bordet
Brussels, BelgiumLudwig Institute for Cancer Research
Brussels, Belgium