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

NCT01436565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-06-13

No results posted yet for this study

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

Conditions

  • Solid Tumor Cancers

Interventions

DRUG

MM-121 (SAR256212)

Pharmaceutical form:solution Route of administration: Intravenous

DRUG

SAR245408

Pharmaceutical form:tablet Route of administration: oral

Sponsors & Collaborators

  • Merrimack Pharmaceuticals

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436565 on ClinicalTrials.gov