A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314922
• Other study ID #: INCB 50465-111/CITADEL-111
• Secondary ID: Parsaclisib
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2018
• Est. completion date: March 9, 2023

Study information

• Verified date: August 2023
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 9, 2023
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 PI3Kd 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• Parsaclisib
Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose.

Locations

Country	Name	City	State
Japan	Aichi Cancer Center Hospital	Aichi
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Cancer Institute Hospital of Jfcr	Koto-ku
Japan	Nagoya City University Hospital	Nagoya
Japan	Tohoku University Hospital	Sendai-shi
Japan	National Cancer Center Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Objective response rate	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
Secondary	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
Secondary	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