Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Solid Tumor Clinical Trial

Official title: An Open-label, Two-treatment Crossover Pharmacokinetic Interaction Study of Repeated Doses of SAR302503 on Pharmacokinetics of a Single Dose Cocktail of Omeprazole, Metoprolol, and Midazolam Used as Probe Substrates for CYP2C19, CYP2D6 and CYP3A4 Activities, Respectively in Adult Patients With Refractory Solid Tumors

Status Completed

Clinical Trial Summary

Primary Objective:

• To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).

• To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.

Secondary Objectives:

• To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1

• To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2

• To determine antitumor activity in Segment 2

Clinical Trial Description

The duration of the study for an individual patient will include a period to assess eligibility (screening period 21 days), followed by a treatment period of at least 15 days of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. However, treatment may continue if patients are receiving benefit and do not have unacceptable toxicity or meet study withdrawal criteria. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

• NCT number: NCT01585623
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Completion date: March 2013