This study has two phases, a dose escalation phase and a dose expansion phase. For dose escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoint for this objective will be occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2 dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), assessment of clinical laboratory values, and vital sign measurements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
City of Hope National Medical Center
Duarte, California, United States
Washington University School of Medicine Div. of Medical Oncology
St Louis, Missouri, United States
Hackensack University Medical Center Hackensack (SC)
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center MSK 2
New York, New York, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State
Columbus, Ohio, United States
University of Texas/MD Anderson Cancer Center SC Location
Houston, Texas, United States
Novartis Investigative Site
Créteil, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Pierre-Benite Cédex, France
Novartis Investigative Site
Rouen, France
...and 14 more locations
Frequency of Dose Limiting Toxicity (DLT) during cycle 1 (Dose Escalation phase)
Time frame: Cycle 1 (28 days)
Number of Pparticipants reporting Serious Adverse Events and Adverse Events (Dose Expansion phase)
Time frame: Baseline, 28 days
Overall Response Rate, using NHLIWG criteria
Assess the overall response rate to AEB071
Time frame: Baseline, 12 months
Number of Participants reporting Serious Adverse Events and Adverse Events
Time frame: Baseline, 12 months
AEB071 PK parameters including Cmax, tmax, AUCt, Ctrough, CL/F and RA
Evaluate the single and multiple dose PK of AEB071 in patients with Diffuse Large B-Cell Lymphoma (DLBCL)
Time frame: First 7 months of treatment period
Pre and post-dose gene and protein expression of cytokines and any correlations with exposure to AEB071
Assess the pharmacodynamic response to AEB071 in Lymphoma and blood specimens
Time frame: First 7 months of treatment period
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