Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517; IND-73969) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction."

--Histologically or cytologically confirmed solid tumor or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients with a liver mass, elevated alpha-fetoprotein level (>/= 500 ng/mL) and positive serology for viral hepatitis, consistent with a diagnosis of hepatocellular carcinoma are eligible. All solid and lymphoma tumor types are eligible.
--X-rays and/or scans for disease assessment must have been completed within 28 days (for measurable disease) or 42 days (for non-measurable disease) prior to registration.
--Stable or decreasing dose of corticosteroids for brain metastases ok. For known brain metastases must have had brain irradiation (whole brain or gamma knife). Untreated (non-irradiated) brain metastases are not eligible. Must not be taking enzyme-inducing anticonvulsant mediations (e.g. phenobarbital, phenytoin or carbamazepine).
--PS of 0 - 2
--18 years of age or older.
--Must have adequate marrow, renal and chemistry function as defined below:
ANC >/= 1.5 x 10 e9/L
Platelets >/= 100 x 10 e9/L
Magnesium >/= LLN
Potassium >/= LLN
Creatinine >/= 1.5 x ULN OR Calculated creatinine clearance >/= 60 mL/min/1.73 m2
--Abnormal liver function ok; LFTs (total bilirubin, AST/ALT, PT/INR and PTT, and alkaline phosphatase) must
be performed within 14 days prior to registration.
--Patients with biliary obstruction for which a shunt has been placed are eligible.
--Must not be taking H2-receptor antagonists or any proton pump inhibitors.
--Must not be pregnant or nursing.
--Must be willing to undergo pharmacokinetic sampling as outlined in Section 15.2.
--Must not have had anticancer therapy including dasatinib, chemotherapy, radiotherapy, immunotherapy, or investigational agent within 4 weeks prior to registration, except for targeted agents with half-life known to be < 24 hours; must not have had targeted agents with half-life < 24 hours within 2 weeks prior to registration.
--Must not be planning to receive concurrent radiation, other chemotherapy, immune therapy or any other investigational agents for malignancy while receiving protocol treatment; Hormonal treatment for prostate carcinoma may be continued and bisphosphonate treatment for bone disease is permitted.
--Must not have had major surgical procedures within the last 4 weeks prior to the first planned dose of study drug.
--Must not have had the following conditions w/in 12 months prior to starting protocol treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or significant pulmonary embolus.
--Must not have ongoing cardiac dysrhythmias of NCI CTCAE Grade >/= 2, atrial fibrillation of any grade, or QTc interval > 470 msec for females or > 450 msec for males.
--Must not have baseline pleural effusion.
--Must not be taking therapeutic doses of anticoagulants. Low dose warfarin for port prophylaxis is permitted.
--Must not have active gastrointestinal bleeding.
--Patients with the inability to take oral medications, with a diagnosis of malabsorption syndromes or with significant bowel resection affecting absorption are not eligible.
--Must not have clinically significant pleural effusion/ fluid retention/ pericardial effusion.
--Must not have uncontrolled serious intercurrent medical illness including, but not limited to ongoing or serious active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, uncontrolled diarrhea or psychiatric illness.
--Must not be HIV-positive