Neoplasm Malignant Clinical Trial
Official title:
An Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of SAR245408 Administered Orally Daily in Patients With Solid Tumors
Primary Objective:
- To confirm safety and tolerability of global recommended phase three dose (RPTD) of
SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with
solid tumors.
Secondary Objectives:
- To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408
in CDD treatment schedule in patients with solid tumors.
- To gather preliminary efficacy data after repeated administration of SAR245408 in
patients with solid tumors.
The duration of the study for 1 patient will include a period for screening up to 28 days, the study treatment period, followed by a 28-day follow-up after the last study drug administration. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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