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

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio

Criteria

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