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

Incyte

Status and phase

Completed

Phase 1

Conditions

Lymphoma

Treatments

Drug: Parsaclisib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03314922

Parsaclisib (Other Identifier)

INCB 50465-111/CITADEL-111

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.