| Exclusion Criteria: | 1) The patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
2) Has a B-cell lymphoma, primary CNS lymphoma, or known lymphomatous involvement of the CNS, or other NK/T-cell leukemias/lymphomas such as:precursor T-lymphoblastic; lymphoma/leukemia;T-cell prolymphocytic leukemia; T-cell granular lymphocytic leukemia; NK-cell leukemia; anaplastic large cell lymphoma, T/null-cell, primary cutaneous type, (if only a single site of disease); non-transformed mycosis fungoides; sezary syndrome.
3) Has uncontrolled or poorly controlled hypertension (> 160/90 mmHg).
4) Has had recent (within 1 month prior to Day 1) serious surgery or uncontrolled infectious disease.
5) Has any concurrent malignancy requiring treatment.
6) Has a known positive test for Hepatitis B surface Ag, Hepatitis C, or HIV.
7) Has any of the following laboratory abnormalities: Bone marrow impairment: ANC < 1,000/microL (1 x 10^9/L); platelets < 50,000/microL (50 x 10^9/L); Impairment of renal function: creatinine > 1.5 mg/dL (114.4 micromol/L) unless measured CrCl >/= 60 mL/minute (1.002 mL/s); Abnormal liver function: AST/ALT > 3x ULN (up to 5x ULN with liver involvement); bilirubin > 2.0 mg/dL (25.7 micromol/L).
8) Has difficulty swallowing or malabsorption.
9) Has an ECOG performance status > 2.
10) Has not recovered from adverse effects related to last prior therapy for lymphoma.
11) Has had an allotransplantation within 90 days prior to Day 1 of treatment.
12) Has been treated with a CYP3A4 inducer/inhibitor within 3 days prior to Day 1 of treatment or is expected to require treatment with CYP3A4 inducer/inhibitor during the course of the study. Refer to Appendix III (the active metabolite of R788 is metabolized by CYP3A4, and ketoconazole increases the AUC of a dose of R788 by approximately 2-fold).
13) Has received systemic steroids at a dose greater than the equivalent of 10 mg/day of prednisone within 7 days prior to Day 1 of treatment. Systemic steroids at a dose less than the equivalent of 10 mg/day of prednisone and inhaled, nasal, and topical steroids are permitted. Intermittent dexamethasone for the treatment of nausea/ emesis is also permitted.
14) Has received any other investigational therapy within 5 half-lives of the agent or 2 weeks of Day 1 of treatment, whichever is longer.
15) Is a female of childbearing potential unless menopausal, surgically sterile, or willing to use an effective method of birth control, (oral contraceptive, mechanical barrier, long-acting hormonal agent), during the study and for 30 days thereafter.
16) Is pregnant or lactating: all females of childbearing potential must have a negative urine pregnancy test within 7 days of Day 1 of study drug administration. |