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

Date de début de l'étude : 1 avril 1999

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