Status:
TERMINATED
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
Lead Sponsor:
SecuraBio
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01476657
Start Date
October 1 2011
End Date
January 1 2017
Last Update
March 17 2021
Active Locations (4)
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1
New York, New York, United States, 10065
2
Columbus, Ohio, United States, 43210
3
Nashville, Tennessee, United States, 37203
4
Houston, Texas, United States, 77030