Hematologic Malignancies
Conditions
Keywords
Phase 1
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.
Interventions
Oral Twice A Day (BID) Dosing
Sponsors
SecuraBio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed