Lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : INCB050465
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mater
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of participants with treatment-emergent adverse events 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 |
|---|---|
| efficacy pharmacokinetics 1.Changes in pharmacodynamic (PD) markers of B-cell activation in plasma 2.Objective response rate 3.Duration of response 4.Progression-free survival 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. 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. 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. 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. | — |
Countries
Japan
Outcome results
None listed