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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose.
Aichi Cancer Center Hospital
Aichi, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Cancer Institute Hospital of Jfcr
Kōtoku, Japan
Nagoya City University Hospital
Nagoya, Japan
Number of participants with treatment-emergent adverse events (TEAEs)
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.
Time frame: Up to approximately 1 year
Changes in pharmacodynamic (PD) markers of B-cell activation in plasma
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.
Time frame: Up to 24 weeks
Objective response rate
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.
Time frame: Up to approximately 1 year
Duration of response
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.
Time frame: Up to approximately 1 year
Progression-free survival
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.
Time frame: Up to approximately 1 year
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Tohoku University Hospital
Sendai, Japan
National Cancer Center Hospital
Tokyo, Japan