A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
- Conditions
- ymphoma
- Registration Number
- JPRN-jRCT2080224158
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Parsaclisib was shown to be safe and tolerable in Japanese participants with relapsed or refractory B-cell malignancies at parsaclisib 20 mg QD for 8 weeks followed by the same dose once weekly. Parsaclisib was not associated with significant transaminase elevations or with any new or unexpected AEs in the Japanese population. Based on preliminary analyses, the PK profile of parsaclisib in Japanese participants is comparable to the profile in the US population and no dose modifications are recommended.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 17
1) 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.
2) Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
3) Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
4) 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.
5) Life expectancy > 3 months.
6) Eastern Cooperative Oncology Group performance status of 0 to 2.
7) Adequate hematologic, hepatic, and renal function.
1) Evidence of transformed non-Hodgkin's lymphoma histologies.
2) Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
3) History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
4) Prior treatment with idelalisib, other selective PI3K delta inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
5) 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.
6) Active graft-versus-host disease.
7) History of stroke or intracranial hemorrhage within 6 months of study drug administration.
8) 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.
9) Known human immunodeficiency virus infection.
10) Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Number of participants with treatment-emergent adverse events<br>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 efficacy<br>pharmacokinetics<br>1.Changes in pharmacodynamic (PD) markers of B-cell activation in plasma<br>2.Objective response rate <br>3.Duration of response <br>4.Progression-free survival<br><br>1. 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.<br>2. 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.<br>3. 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.<br>4. 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.