A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

Inclusion Criteria:

- ≥ 18 years of age;

- Progressed during, refractory to, intolerant of, or ineligible for established
therapy, or has a disease with no established therapy with the exception of expansion
cohort of treatment naïve CLL patients;

- An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.

Exclusion Criteria:

- Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks
of the start of IPI-145 administration (Expansion Phase);

- Patients with overt leptomeningeal leukemia or CNS lymphoma;

- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine
aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x
ULN;

- Inadequate renal function defined by serum creatinine > 1.5 x ULN