Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

Study Identifier
M15-460
CT.gov Identifier
NCT02598570
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
    • Study Drug
  • duvelisib
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    20 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of lymphoma (excluding lymphoblastic lymphoma) * Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy * Eastern Cooperative Oncology Group (ECOG) performance status lower than or equal to 2 * Life expectancy of at least 3 months
    Exclusion Criteria:
    * Any prior treatment with a PI3K inhibitor or Bruton's tyrosine kinase (BTK) inhibitor * Ongoing treatment with chronic immune-suppressants * Overt CNS lymphoma * Inadequate hepatic, bone marrow, or renal function * History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months * Venous thromboembolic event requiring anticoagulation * Presence of active systemic infection within 72 hours of treatment * Human immunodeficiency virus (HIV) infection * Pregnant or lactating women

    Protocol Summary

    This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 141826
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 141595
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 141594
    Tokyo, Japan
    Status
    Not applicable