A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
Phase 1
Terminated
- Conditions
- Hematologic Malignancies
- Interventions
- Drug: IPI-145 (duvelisib)
- Registration Number
- NCT01476657
- Lead Sponsor
- SecuraBio
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 210
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IPI-145 IPI-145 (duvelisib) IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles.
- Primary Outcome Measures
Name Time Method Safety and Tolerability At least 28 days (1 Cycle) To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.
- Secondary Outcome Measures
Name Time Method