A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
- Registration Number
- NCT01596270
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Twice daily dosing SAR245409 escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose Once daily dosing SAR245409 escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities Up to Day 28
- Secondary Outcome Measures
Name Time Method Maximum SAR245409 plasma concentration Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 Number of patients with treatment-emergent adverse events From first dose of SAR245409 until 30 days after the last dose Area under the SAR245409 plasma concentration versus time curve Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing Days 1, 2, 3, and 4 of the food interaction period Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing Days 1, 2, 3, and 4 of the food interaction period
Trial Locations
- Locations (3)
Investigational Site Number 840001
🇺🇸Detroit, Michigan, United States
Investigational Site Number 840002
🇺🇸New Brunswick, New Jersey, United States
Investigational Site Number 840003
🇺🇸Dallas, Texas, United States