Lymphoma
Conditions
Keywords
Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), phosphatidylinositol 3-kinase (PI3K)
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.
Interventions
DRUGParsaclisib
Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Outcome results
None listed