Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborator: Infinity Pharmaceuticals, Inc.

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