A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma
- Registration Number
- NCT01943838
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAR245408 polymorph E tablets SAR245408 Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities Up to Day 28
- Secondary Outcome Measures
Name Time Method Maximum SAR245408 plasma concentration Days 1, 2, 8, 15, 29 and 30 Area under the SAR245408 plasma concentration versus time curve Days 1, 2, 8, 15, 29 and 30 Number of patients with treatment-emergent adverse events From first dose of SAR245408 up to 30 days after the last dose
Trial Locations
- Locations (1)
Investigational Site Number 056001
🇧🇪Leuven, Belgium