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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03314922
Recruitment Status : Active, not recruiting
First Posted : October 19, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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
Lymphoma Drug: Parsaclisib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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 : June 5, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


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 Name: INCB050465




Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314922


Locations
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Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan, 811-1395
Tohoku University Hospital
Sendai-shi, Miyagi, Japan, 980-8574
Nagoya City University Hospital
Nagoya, Mizuho-ku, Japan, 467-8602
Aichi Cancer Center
Chikusa-KU, Nagoya, Japan, 464-8681
National Cancer Center
Chuo Ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Cinthya Coronado, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03314922    
Other Study ID Numbers: INCB 50465-111/CITADEL-111
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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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:
Diffuse large B-cell lymphoma (DLBCL)
follicular lymphoma (FL)
marginal zone lymphoma (MZL)
mantle cell lymphoma (MCL)
phosphatidylinositol 3-kinase (PI3K)
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin