NCT01392924

Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors

An Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of SAR245408 Administered Orally Daily in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR245408	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2014-11-01
• First posted: 2011-07-13
• Last updated: 2014-12-03

Locations

2 sites across 1 country: Japan