- The patient must be, in the judgment of the investigator, an appropriate candidate
for experimental therapy after available standard therapies have ceased to provide
clinical benefit for their disease.
- The patient must have histological or cytological evidence of cancer, either a solid
tumor or a lymphoma, which is advanced and/or metastatic.
- Have adequate organ function including:
- Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 109/L, platelets ≥100 x
109/L, and hemoglobin ≥8 g/dL.
- Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN) and alanine
aminotransferase (ALT) ≤3.0 times ULN.
- Renal: Serum creatinine ≤1.5 times ULN.
- Have a performance status less than or equal to 1 for Dose Escalation and less than
or equal to 2 for Dose Confirmation on the Eastern Cooperative Oncology Group (ECOG)
- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for
myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving
study drug, and recovered from the acute effects of therapy (treatment-related
toxicity resolved to baseline) except for residual alopecia.
- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 3 months following the last dose
of study drug.
- Females with childbearing potential must have a negative serum pregnancy test within
7 days of the first dose of study drug.
- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days of the initial dose of study drug for a
nonmyelosuppressive or myelosuppressive agent, respectively.
- Have serious preexisting medical conditions that, in the judgment of the
investigator, would preclude participation in this study (for example, inflammatory
bowel disease or history of major surgical resection involving the stomach or small
- Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or
diarrhea (acute or chronic).
- Females who are pregnant or lactating.
- Have CNS malignancy or metastasis.
- Have an acute leukemia.
- Have active bacterial, fungal and/or known viral infection.