Back to resultsA Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Parsaclisib
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), phosphatidylinositol 3-kinase (PI3K)
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.
Sites / Locations
- Aichi Cancer Center Hospital
- National Hospital Organization Kyushu Cancer Center
- Cancer Institute Hospital of Jfcr
- Nagoya City University Hospital
- Tohoku University Hospital
- National Cancer Center Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parsaclisib
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03314922
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
March 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), phosphatidylinositol 3-kinase (PI3K)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parsaclisib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose.
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs)
Description
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.
Time Frame
Up to approximately 1 year
Secondary Outcome Measure Information:
Title
Changes in pharmacodynamic (PD) markers of B-cell activation in plasma
Description
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.
Time Frame
Up to 24 weeks
Title
Objective response rate
Description
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.
Time Frame
Up to approximately 1 year
Title
Duration of response
Description
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.
Time Frame
Up to approximately 1 year
Title
Progression-free survival
Description
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.
Time Frame
Up to approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cinthya Coronado, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464 8681
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Cancer Institute Hospital of Jfcr
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
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