A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
This trial has been terminated.
|Start date||October 2011|
|End date||December 2016|
|Trial size||210 participants|
|Trial identifier||NCT01476657, IPI-145-02|
The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Safety and Tolerability
time frame: At least 28 days (1 Cycle)
Male or female participants at least 18 years old.
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
|Official title||A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies|
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