A Study of DSP-0337 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile

Inclusion Criteria

• •1. Histologically or cytologically confirmed diagnosis of advanced cancer in patients with solid tumors that are refractory to standard treatment, or for whom no effective therapy exists.
• •2. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• •3. Patients must be at least 18 years of age.
• •4. Organ function must be adequate as follows:
• •* Bone Marrow Reserve: absolute neutrophil count ≥ 1.5 x 10\^9/L; platelet count ≥ 100 x 10\^9/L; hemoglobin ≥ 9.0 g/dL. Must not have required blood transfusion within 1 week of baseline blood count assessment.
• •* Hepatic: bilirubin \< 1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) \< 3.0 x ULN (AP, AST, and ALT \< 5 x ULN is acceptable if the liver has tumor involvement).
• •* Renal: serum creatinine within normal limits; for patients with levels above the institutional normal value, the calculated corrected creatinine clearance must be ≥ 60 mL/min/1.73 m\^2 using the Cockcroft-Gault formula corrected for the body surface area.
• •5. Toxicities incurred as a result of previous anti cancer therapy (radiation therapy \[RT\], chemotherapy, or surgery) must be resolved to ≤ Grade 1 except for alopecia and anorexia.
• •6. Patients must provide written informed consent.
• •7. Female patients are eligible for the study if they meet the following criteria:
• •* Are not pregnant or nursing;
• •* Of non-childbearing potential defined as women who have had a hysterectomy, bilateral oophorectomy, medically documented ovarian failure, or are documented postmenopausal (follicle stimulating hormone \> 40 mIU/mL); OR,
• •Of childbearing potential defined as including women \< 55 years of age, even those who have experienced 2 years of amenorrhea; all women should also meet both of the following criteria:
• •* A negative serum or urine pregnancy test during Screening,
• •* Sexually abstinent or correct and consistent use of one of the following methods of birth control in addition to a male partner using a condom from Screening to 3 months after the last dose of study drug:
• •* hormone-containing contraceptive intrauterine device with a failure rate of \< 1% per year,
• •* cervical cap or diaphragm with a spermicidal agent,
• •* tubal sterilization, or
• •* vasectomy in male partner. Male patients must agree to sexual abstinence or to consistently and correctly use a condom in combination with one of the above methods of birth control from Screening to 3 months after the last dose of study drug.
• •8. Life expectancy must be ≥ 3 months.