Neoplasm Malignant Clinical Trial
Official title:
A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma
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). ;
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