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A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Primary Objective:
To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Group A.
Secondary Objectives:
To assess the duration of response (DOR) in Group A.
To assess progression-free survival (PFS) in Group A.
To assess overall survival (OS) in Group A.
To characterize the safety of INCB050465 in Group A and Group B.
Exploratory Objectives:
To assess the ORR, DOR, PFS, and OS in Group B.
To characterize the population pharmacokinetics (PK) and exposure-response of INCB050465.
To explore potential predictive biomarkers to identify subgroups that would benefit most from treatment with INCB050465.
Primary Objective:
To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Group A.
Secondary Objectives:
To assess the duration of response (DOR) in Group A.
To assess progression-free survival (PFS) in Group A.
To assess overall survival (OS) in Group A.
To characterize the safety of INCB050465 in Group A and Group B.
Exploratory Objectives:
To assess the ORR, DOR, PFS, and OS in Group B.
To characterize the population pharmacokinetics (PK) and exposure-response of INCB050465.
To explore potential predictive biomarkers to identify subgroups that would benefit most from treatment with INCB050465.
Recruitment Status
Past Studies