drugset / Trial / NCT01436565
A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2011-11
- Primary completion
- 2014-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Seribantumab | Monoclonal antibody | — | Intravenous |
| Subject | pilaralisib | Small molecule | — | Oral |
Indications
No indication recorded.