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

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

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