NCT01436565

A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors. Secondary Objectives: * To characterize the global safety profile of SAR245408 in combination with SAR256212 * To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination * To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only) * To determine the immunogenicity of SAR256212 as administered with SAR245408

Detailed description

There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

Conditions

• Solid Tumor Cancers

Interventions

Type	Name	Description
DRUG	MM-121 (SAR256212)	Pharmaceutical form:solution Route of administration: Intravenous
DRUG	SAR245408	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-09-19
• Last updated: 2014-06-13

Locations

3 sites across 1 country: United States