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| Name | Class |
|---|---|
| Infinity Pharmaceuticals, Inc. | INDUSTRY |
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This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| duvelisib | Experimental | Duvelisib will be administered orally as a fixed dose in 28-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duvelisib | Drug | Duvelisib will be administered orally as a fixed dose in 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting Treatment-emergent Adverse Events | The number of participants reporting treatment-emergent adverse events. | Throughout the study for approximately 2 years |
| Maximum Observed Plasma Concentration (Cmax) of Duvelisib | Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5 | |
| Time to Maximum Observed Concentration (Tmax) of Duvelisib | Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5 | |
| Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib | Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall Response Rate is defined as the proportion of participants with a confirmed response of complete (CR) or partial response (PR) based on the revised International Working Group (IWG) criteria. | Throughout the study for approximately 2 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 141826 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 141595 |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C586691 | duvelisib |
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Overall survival is defined as the duration in weeks from the date of the first dose of study treatment until the date of death. |
| Throughout the study for approximately 2 years |
| Progression Free Survival | Progression free survival is defined as the time from the date of the first dose of study treatment to the first documentation of progressive disease (PD) or death due to any cause. | Throughout the study for approximately 2 years |
| Fukuoka |
| Japan |
| Site Reference ID/Investigator# 141594 | Tokyo | Japan |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |