Description:
The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma
The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma
Recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
parsaclisib | INCB050465 | parsaclisib |
Name | Type | Description | Interventions |
---|---|---|---|
parsaclisib | Experimental | parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits |
|
Inclusion Criteria: - Male or female Japanese participant who must be ≥ 18 years of age - Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a - Ineligible for HSCT - Must have been treated with at least 2 prior systemic therapies for FL - ECOG performance status 0 to 2 - Life expectancy ≥ 12 weeks - Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration. - Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study. - Male participants should avoid fathering children from screening through at least 90 days after the last dose of study treatment. Exclusion Criteria: - Known histological transformation from indolent NHL to DLBCL - History of central nervous system lymphoma (either primary or metastatic) - Prior treatment with the following: 1. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc). 2. Bruton's tyrosine kinase inhibitor (eg, ibrutinib). - Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months before the date of study treatment administration - Active graft-versus-host disease - Use of immunosuppressive therapy within 28 days of the date of study treatment administration - Concurrent anticancer therapy - Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease - Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval. - Hepatitis B (HBV) or HCV infection - Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Objective response rate (ORR) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014), as determined by an IRC |
Measure: | Complete response rate (CRR) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an IRC. |
Measure: | Duration of response (DOR) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC. |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. |
Measure: | Overall survival |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the date of the first dose of study treatment until death from any cause |
Measure: | Best percentage change in target lesion size |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of the diameters of all target lesion sizes. |
Measure: | Number of participants with treatment-emergent adverse events (TEAEs) |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | 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. |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Incyte Biosciences Japan GK |
October 6, 2020