A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies
Inclusion Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following advanced malignancies: Breast
Colorectal Non-small cell lung Gastric Pancreatic Renal Prostate Myeloma Failed standard
therapy OR No effective standard therapy exists Measurable or evaluable disease No known
CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not
specified Performance status: Karnofsky 60-100% Life expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL AST
and ALT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2
mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction
or severe/unstable angina within the past 6 months No evidence of uncompensated coronary
artery disease by electrocardiogram or physical exam Other: No other malignancy within the
past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No
insulin-dependent diabetes mellitus No non-insulin-dependent diabetes mellitus with
clinical evidence of severe peripheral vascular disease or diabetic ulcers No
manifestation of malabsorption due to prior surgery, GI disease, or unknown reasons No
active inflammatory bowel disease No known intolerance to any excipients in the study drug
formulation No other acute or chronic medical or psychiatric condition or laboratory
abnormality that would preclude study Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior anticancer
biologic or immunotherapy and recovered No prior SU006668 No other concurrent
immunotherapy Chemotherapy: At least 4 weeks since prior anticancer chemotherapy (6 weeks
for nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy:
At least 4 weeks since prior hormonal therapy No concurrent hormonal therapy except for
hormonal contraception or appetite stimulation Radiotherapy: Recovered from prior
radiotherapy Surgery: At least 6 weeks since prior surgery At least 6 months since prior
coronary/peripheral artery bypass graft surgery Prior major GI surgery allowed if no
residual syptomatic manifestation of malabsorption No prior organ transplantation Other:
At least 4 weeks since prior investigational agents No other concurrent investigational
agents