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

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03314922
Collaborator
(none)
17
6
1
55.9
2.8
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Aug 2, 2018
Actual Primary Completion Date :
May 5, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Parsaclisib

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.
Other Names:
  • INCB050465
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-emergent adverse events (TEAEs) [Up to approximately 1 year]

      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.

    Secondary Outcome Measures

    1. Changes in pharmacodynamic (PD) markers of B-cell activation in plasma [Up to 24 weeks]

      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.

    2. Objective response rate [Up to approximately 1 year]

      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.

    3. Duration of response [Up to approximately 1 year]

      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.

    4. Progression-free survival [Up to approximately 1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aichi Cancer Center Hospital Aichi Japan 464 8681
    2 National Hospital Organization Kyushu Cancer Center Fukuoka Japan 811-1395
    3 Cancer Institute Hospital of Jfcr Koto-ku Japan 135-8550
    4 Nagoya City University Hospital Nagoya Japan 467-8602
    5 Tohoku University Hospital Sendai-shi Japan 980-8574
    6 National Cancer Center Hospital Tokyo Japan 104-0045

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Cinthya Coronado, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT03314922
    Other Study ID Numbers:
    • INCB 50465-111/CITADEL-111
    • Parsaclisib
    First Posted:
    Oct 19, 2017
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Incyte Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2022