A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers
- Registration Number
- NCT01436565
- Lead Sponsor
- Sanofi
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dose escalation and expansion MM-121 (SAR256212) SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose dose escalation and expansion SAR245408 SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 2 months to 12 months
- Secondary Outcome Measures
Name Time Method overall response rate 2 months to 2 years Pharmacodynamic change in ErbB3 protein and mRNA levels as well as components of the PI3K pathway will be measured 1 month to 6 months Number of patients who develop anti-MM-121 antibodies 1 month to 6 months Peak and trough levels of SAR256212 and SAR245408 1 month to 6 months Number of participants with adverse events 1 month to 2 years
Trial Locations
- Locations (3)
Investigational Site Number 840001
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 840101
🇺🇸Brookline, Massachusetts, United States
Investigational Site Number 840002
🇺🇸Nashville, Tennessee, United States