A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
A Phase 1b, Open-Label, Dose-Escalation Study for the Safety, Tolerability, and Pharmacokinetics of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
2 other identifiers
interventional
17
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 lymphoma
Started Aug 2018
Typical duration for phase_1 lymphoma
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2023
CompletedAugust 14, 2023
August 1, 2023
1.8 years
October 16, 2017
August 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Changes in pharmacodynamic (PD) markers of B-cell activation in plasma
Up to 24 weeks
Objective response rate
Up to approximately 1 year
Duration of response
Up to approximately 1 year
Progression-free survival
Up to approximately 1 year
Study Arms (1)
Parsaclisib
EXPERIMENTALInterventions
Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose.
Eligibility Criteria
You may qualify if:
- 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.
- Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
- Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
- 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.
- Life expectancy \> 3 months.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Adequate hematologic, hepatic, and renal function.
You may not qualify if:
- Evidence of transformed non-Hodgkin's lymphoma histologies.
- Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
- History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
- 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.
- Active graft-versus-host disease.
- History of stroke or intracranial hemorrhage within 6 months of study drug administration.
- 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.
- Known human immunodeficiency virus infection.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Aichi Cancer Center Hospital
Aichi, 464 8681, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Cancer Institute Hospital of Jfcr
Kōtoku, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cinthya Coronado, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2017
First Posted
October 19, 2017
Study Start
August 2, 2018
Primary Completion
May 5, 2020
Study Completion
March 9, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
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.