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

NCT ID: NCT03314922

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2023-03-09

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parsaclisib

Group Type: EXPERIMENTAL

Parsaclisib

Intervention Type: DRUG

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

Interventions

Parsaclisib

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

Intervention Type: DRUG

Other Intervention Names

INCB050465

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cinthya Coronado, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Aichi Cancer Center Hospital

Aichi, , Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Cancer Institute Hospital of Jfcr

Kōtoku, , Japan

Nagoya City University Hospital

Nagoya, , Japan

Tohoku University Hospital

Sendai, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

Parsaclisib

Identifier Type: OTHER

Identifier Source: secondary_id

INCB 50465-111/CITADEL-111

Identifier Type: -

Identifier Source: org_study_id