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Phase 1 Safety Testing of SAR405838

NCT01636479 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2018-05-17

No results posted yet for this study

Summary

Primary Objectives:

* To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).
* To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion.

Secondary Objectives:

* Pharmacokinetic (PK) profile of SAR405838.
* Biomarkers in association with SAR405838.
* Anti-tumor activity in response to SAR405838.
* Food effect on SAR405838 PK.
* Compliance with SAR405838 treatment.
* Cytochrome P450 3A4/5 (CYP3A4/5) activity.

Conditions

  • Neoplasm Malignant

Interventions

DRUG

SAR405838

Pharmaceutical form: Capsule Route of administration: Oral

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
2012-07-13
Primary Completion
2018-03-05
Completion
2018-03-05

Countries

  • United States
  • France
  • Netherlands

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 NCT01636479 on ClinicalTrials.gov