MedTrace Logo

Effect of SAR302503 on ECG Activity in Patients With Solid Tumors

NCT01836705 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-05

No results posted yet for this study

Summary

Primary Objective:

\- To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the QTcF interval compared to 1-day placebo in patients with advanced solid tumors.

Secondary Objectives:

* To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo.
* To assess the clinical and laboratory safety of SAR302503
* To document the plasma concentrations of SAR302503 at the time of ECG investigation.
* To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503 concentration and QTcF
* To explore antitumor activity

Conditions

  • Neoplasm Malignant

Interventions

DRUG

SAR302503 (TG101348)

Pharmaceutical form:capsule Route of administration: oral

DRUG

Placebo SAR302503

Pharmaceutical form:capsule Route of administration: oral

DRUG

Panolosetron

Pharmaceutical form:solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-11-30
Completion
2014-05-31

Countries

  • United States
  • Belgium

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 NCT01836705 on ClinicalTrials.gov