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Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients

NCT01657214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-02-17

No results posted yet for this study

Summary

Primary Objective:

In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844.

In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients).

Secondary Objectives:

To characterize and confirm the global safety profile of SAR125844 including cumulative toxicities.

To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the relationship of MET gene amplification status with antitumor effects.

To evaluate other pharmacodynamic biomarkers.

Conditions

  • Neoplasm Malignant

Interventions

DRUG

SAR125844

Pharmaceutical form:Concentrate for solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

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 NCT01657214 on ClinicalTrials.gov