Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors
- Registration Number
- NCT01392924
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAR245408 SAR245408 single cohort: SAR245408 administered once daily
- Primary Outcome Measures
Name Time Method Dose limiting toxicity in cycle 1 4 weeks
- Secondary Outcome Measures
Name Time Method Number of treatment emergent adverse events 28 days after the last dosing Number of serious adverse events 28 days after the last dosing Number of abnormality of laboratory test as graded by National Cancer Institute-Common Toxicity Criteria 28 days after the last dosing Pharmacokinetics (Cmax) of SAR245408 an expected average of 3 months Cycles 1 and 2, and every 4th cycle after Cycle 4
Pharmacokinetics (tmax) of SAR245408 an expected average of 3 months Cycles 1 and 2, and every 4th cycle after Cycle 4
Pharmacokinetics (AUC) of SAR245408 an expected average of 3 months Cycles 1 and 2, and every 4th cycle after Cycle 4
Pharmacokinetics (accumulation ratio) of SAR245408 an expected average of 3 months Cycles 1 and 2, and every 4th cycle after Cycle 4
Pharmacokinetics (Ctrough) of SAR245408 an expected average of 3 months Cycles 1 and 2, and every 4th cycle after Cycle 4
Objective tumor response as defined by RECIST (response evaluation criteria in solid tumors) At 8 weeks and every 2 months thereafter
Trial Locations
- Locations (2)
Investigational Site Number 392002
🇯🇵Kobe-Shi, Japan
Investigational Site Number 392001
🇯🇵Nagoya-Shi, Japan