A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma
- 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Dose Limiting Toxicities [ Time Frame: Up to Day 28 ]
- Number of patients with treatment-emergent adverse events [ Time Frame: From first dose of SAR245408 up to 30 days after the last dose ]
- Maximum SAR245408 plasma concentration [ Time Frame: Days 1, 2, 8, 15, 29 and 30 ]
- Area under the SAR245408 plasma concentration versus time curve [ Time Frame: Days 1, 2, 8, 15, 29 and 30 ]
|Study Start Date:||October 2013|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: SAR245408 polymorph E tablets
Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles
Pharmaceutical form: tablet Route of administration: oral
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01943838
|Investigational Site Number 056001|
|Leuven, Belgium, 3000|
|Study Director:||Clinical Sciences & Operations||Sanofi|