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| ID | Type | Description | Link |
|---|---|---|---|
| Parsaclisib | Other Identifier | Incyte Corporation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parsaclisib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 weeks |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cinthya Coronado, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Aichi | 464 8681 | Japan | |||
| National Hospital Organization Kyushu Cancer Center |
Data will be made available at the end of trial or termination of trial. The following data will be made available: safety, PK and PD, efficacy, and subject characteristics. The results of the trial will be published. In addition, data as documented in study CSR will be made available upon request.
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000656179 | parsaclisib |
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|
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. |
| 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. | 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. | Up to approximately 1 year |
| Fukuoka |
| 811-1395 |
| Japan |
| Cancer Institute Hospital of Jfcr | KÅtoku | 135-8550 | Japan |
| Nagoya City University Hospital | Nagoya | 467-8602 | Japan |
| Tohoku University Hospital | Sendai | 980-8574 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |