Clinical trial NCT03314922: A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Keywords: Diffuse large B-cell lymphoma (DLBCL)
follicular lymphoma (FL)
marginal zone lymphoma (MZL)
mantle cell lymphoma (MCL)
phosphatidylinositol 3-kinase (PI3K)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 1 year
Secondary outcomes:
measure: Changes in pharmacodynamic (PD) markers of B-cell activation in plasma
timeFrame: Up to 24 weeks
measure: Objective response rate
timeFrame: Up to approximately 1 year
measure: Duration of response
timeFrame: Up to approximately 1 year
measure: Progression-free survival
timeFrame: Up to approximately 1 year
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of Jfcr
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
Study officials:
affiliation: Incyte Corporation
name: Cinthya Coronado, MD
role: STUDY_DIRECTOR
References: