Status:
COMPLETED
A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
Lead Sponsor:
Incyte Corporation
Conditions:
Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03314922
Start Date
August 2 2018
End Date
March 9 2023
Last Update
August 14 2023
Active Locations (6)
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1
Aichi Cancer Center Hospital
Aichi, Japan, 464 8681
2
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
3
Cancer Institute Hospital of Jfcr
Kōtoku, Japan, 135-8550
4
Nagoya City University Hospital
Nagoya, Japan, 467-8602