Clinical Research Directory

Inclusion Criteria: Patients must fulfill ALL the following inclusion criteria * Age 18 years. * Histologic or cytologic diagnosis of carcinoma, that is either refractory to standard therapy or has no available therapies. * Measurable disease using the RECIST v1.1 criteria * ECOG performance 0 or 1. * Estimated life expectancy of at least 12 weeks. * Adequate bone marrow and renal function as follows: Bone marrow: Absolute neutrophil count (ANC) 1.5 x 109/L Platelets 100 x 109/L Renal: calculated creatinine clearance \>60ml/minute Total bilirubin and AST/ALT as described in Table 1 * Able to swallow pills * Signed informed consent from patient or legal representative * Patients with reproductive potential must use an approved contraceptive method if appropriate (e.g., intrauterine device, birth control pills, or barrier device) during and for three months after the study. * Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. Exclusion Criteria: Patients will be excluded from the study for any of the following reasons: * Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. * Treatment of a small molecule targeted agents ≤ 2 weeks prior to starting study treatment * Treatment within the last 30 days with any investigational drug. * Radiotherapy ≤4 weeks prior to starting study treatment or who have not recovered from radiotherapy-related toxicities. Limited field palliative radiotherapy ≤ 2 weeks prior to starting study treatment is allowed * Major surgery within 28 days of study drug administration. * History or presence of serious uncontrolled ventricular arrhythmias * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TS-1 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) * Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory) * Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. * Pregnancy. * Breast feeding. * Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator. * Poorly controlled diabetes mellitus. * Second primary malignancy that is clinically detectable at the time of consideration for study enrollment * Symptomatic brain metastasis. * History of significant neurological or mental disorder, including seizures or dementia.