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

Stopped early · Phase 1

Conditions studied: Hematologic Malignancies

In brief

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

Key facts

Study ID

NCT01476657

Run by

SecuraBio

People needed

210

Starts

2011-10-01

Expected to finish

2017-01-01

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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

Where it is running

• Study site — New York, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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