A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
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|ClinicalTrials.gov Identifier: NCT03314922|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2017
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Parsaclisib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|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|
|Study Director:||Cinthya Coronado, MD||Incyte Corporation|