Clinical Trial: A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of two INCB050465 treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Detailed Summary:
Sponsor: Incyte Corporation

Current Primary Outcome: Objective response rate based on Lugano Classification criteria [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]

Defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by independent review committee (IRC) assessment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response.
  • Complete response rate based on Lugano Classification criteria. [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the percentage of participants with a CR as determined by an IRC.
  • Progression-free survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression or death from any cause.
  • Overall survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until death from any cause.
  • Best percentage change from baseline in target lesion size [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Target lesion size is measured by the sum of the product of diameters of all target lesion sizes.
  • Safety of INCB050465 as measured by adverse events (AEs) [ Time Frame: Baseline through 30-35 days after end of treatment, up to approximately 15 months per participant. ]
    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.


Original Secondary Outcome: Same as current

Information By: Incyte Corporation

Dates:
Date Received: May 5, 2017
Date Started: August 2017
Date Completion: March 2022
Last Updated: May 5, 2017
Last Verified: May 2017