A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia

Inclusion Criteria:

- Patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL)

- Prior treatment with at least 2 systemic chemotherapy regimens for CLL

- Life expectancy of >3 months

- Adequate liver and kidney function

- Absolute neutrophil count ≥500/mm3; platelets ≥50,000/dL; hemoglobin ≥9 g/dL

- Willing to use accepted method of contraception during the course of the study

- Negative pregnancy test (females)

- Written informed consent

Exclusion Criteria:

- Chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on
the therapy)

- Investigational drug within 30 days of the start of treatment

- Uncontrolled intercurrent illness such as infection or cardiovascular disease

- Pregnant or breastfeeding women

- Subjects known to be HIV positive