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First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor

NCT01156870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2017-05-10

No results posted yet for this study

Summary

Primary Objective:

To determine the maximum tolerated dose (MTD) of SAR566658

Secondary Objectives:

* To characterize the safety profile of SAR566658
* To evaluate the pharmacokinetic profile of SAR566658
* To assess the potential immunogenicity of SAR566658
* To assess preliminary antitumor activity
* To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
* To assess safety in the alternative schedules of SAR566658 administration

Conditions

  • Neoplasm Malignant

Interventions

DRUG

SAR566658

Pharmaceutical form:solution for infusion 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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-08
Primary Completion
2017-04-07
Completion
2017-04-07

Countries

  • United States
  • France
  • Spain

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 NCT01156870 on ClinicalTrials.gov