Neoplasm Malignant Clinical Trial
Official title:
A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245408 Polymorph E Administered Once Daily to Subjects With Solid Tumors or Lymphoma
Primary Objective:
- To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given
once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.
Secondary Objectives:
- To evaluate the pharmacodynamic (PD) effect of SAR245408 given once daily as a tablet
formulation of polymorph E in subjects with solid tumors or lymphoma.
- To explore the antitumor activity of SAR245408 given once daily as a tablet formulation
of polymorph E in subjects with solid tumors or lymphoma.
Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment
visit: no later than 7 days after the last study drug administration Subjects not eligible
for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit
will be performed within 30 ± 3 days after the last study drug administration Subjects
eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll
in the treatment-extension study TED12414.
Total duration of study participation for each patient: 58 to 118 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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