The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.

The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 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