A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

• Status: Active, not recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell lymphoma.

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

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• First generation Japanese; subject was born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry.

• Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.

• Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.

• Willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.

• Life expectancy > 3 months.

• Eastern Cooperative Oncology Group performance status of 0 to 2.

• Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

• Evidence of transformed non-Hodgkin's lymphoma histologies.

• Histologically confirmed, rare non-Hodgkin's B-cell subtypes.

• History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.

• Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.

• Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug.

• Active graft-versus-host disease.

• History of stroke or intracranial hemorrhage within 6 months of study drug administration.

• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of the date of the first dose of study drug.

• Known human immunodeficiency virus infection.

• Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.