Primary Objective: \- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma. Secondary Objectives: * To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma. * To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma. * To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma. * To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire. * To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.
The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
49
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number 840001
Detroit, Michigan, United States
Investigational Site Number 840002
New Brunswick, New Jersey, United States
Investigational Site Number 840003
Dallas, Texas, United States
Dose Limiting Toxicities
Time frame: Up to Day 28
Number of patients with treatment-emergent adverse events
Time frame: From first dose of SAR245409 until 30 days after the last dose
Maximum SAR245409 plasma concentration
Time frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Area under the SAR245409 plasma concentration versus time curve
Time frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing
Time frame: Days 1, 2, 3, and 4 of the food interaction period
Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing
Time frame: Days 1, 2, 3, and 4 of the food interaction period
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