A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
- Registration Number
- NCT03314922
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Parsaclisib Parsaclisib -
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) Up to approximately 1 year TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Secondary Outcome Measures
Name Time Method Changes in pharmacodynamic (PD) markers of B-cell activation in plasma Up to 24 weeks Markers of B-cell activation (eg, B-cell activating factor, interleukin-10, B-cell attracting chemokine) and other plasma analytes will be analyzed for correlation with safety and clinical outcome.
Objective response rate Up to approximately 1 year Defined as the percentage of subjects with complete response (CR)/complete metabolic response (CMR) and partial response (PR)/ partial metabolic response (PMR), as determined by investigator assessment of response according to response criteria for lymphomas.
Duration of response Up to approximately 1 year Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression or death from any cause among subjects who achieve an objective response.
Progression-free survival Up to approximately 1 year Defined as the time from the date of the first dose of study drug until the earliest date of disease progression or death from any cause.
Trial Locations
- Locations (6)
Cancer Institute Hospital of Jfcr
🇯🇵Koto-ku, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Aichi Cancer Center Hospital
🇯🇵Aichi, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Japan