Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations
The goal of the pre-screening part of this clinical research study is to learn your MYC status. MYC is a certain type of genetic biomarker. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug. The goal of the main part of this clinical research study is to learn if CUDC-907 can help to control relapsed or refractory diffuse large B-Cell lymphoma. The safety of this drug and combination will also be studied.
Treatment Location: N/A
Primary Objective To evaluate the efficacy of CUDC-907, as measured by the objective response rate (ORR) in Group B subjects with relapsed and/or refractory (RR) diffuse large B-cell lymphoma (DLBCL) with MYC altered disease by immunohistochemistry (IHC). Secondary Objectives To evaluate ORR (local determination) in Group B subjects. To evaluate progression-free survival (PFS), median PFS, and PFS at 6 months (PFS6) in Group B Subjects. To evaluate overall survival (OS) in Group B subjects. To evaluate the disease control rate (DCR) and duration of response (DOR) in Group B subjects. To evaluate ORR in Group A and C subjects. To evaluate the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and other safety parameters in subjects receiving CUDC-907. To characterize the pharmacokinetics (PK) of CUDC-907. Exploratory Objectives To explore PFS, median PFS, and PFS6, OS, DCR and DOR in Group A and C subjects. To explore the effects of CUDC-907 on disease-associated biomarkers. To explore the relationship between disease-associated biomarkers in plasma and tumor tissue. Among biomarkers of interest, BCL2 and BCL6 protein expression and translocation status in particular will be tested in tumor tissue, where possible. To explore biomarkers of response for patient selection. To explore the relationship between additional biomarkers and biomarker profiles that may influence biologic and clinical responses to CUDC-907. To explore the ORR according to Lugano classification.
IRB Review and Approval Date: 06/08/2016
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
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