Effect of SAR302503 on ECG Activity in Patients With Solid Tumors

Phase 1

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: SAR302503 (TG101348); Drug: Placebo SAR302503; Drug: Panolosetron

• Registration Number: NCT01836705
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Total 7-10 weeks if not progressing to Segment 2. Segment 2 will be additional in 28-day cycles.

Study Timeline

• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Study Start: 2013-05
• Primary Completion: 2013-11
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single-sequence	SAR302503 (TG101348)	SAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days)
Single-sequence	Placebo SAR302503	SAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days)
Single-sequence	Panolosetron	SAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days)

Primary Outcome Measures

Name	Time	Method
QTc Friderica (QTcF) parameter	16 days

Secondary Outcome Measures

Name	Time	Method
Electrocardiographic parameters (Heart Rate)	16 days
Electrocardiographic parameters (QT)	16 days
Electrocardiographic parameters (QTcBazett)	16 days
Electrocardiographic parameters (QTcN)	16 days
Electrocardiographic parameters (PR interval)	16 days
Electrocardiographic parameters (QRS interval)	16 days
Anti-tumor activity	16 or more days
Number of participants with Adverse Events	16 or more days
Pharmacokinetic parameter: Cmax, AUC0-24, Tmax, Tmax, Ctrough	16 days

Trial Locations

Locations (10)

Investigational Site Number 840003; 🇺🇸 Los Angeles, California, United States

Investigational Site Number 840007; 🇺🇸 Augusta, Georgia, United States

Investigational Site Number 840002; 🇺🇸 Detroit, Michigan, United States

Investigational Site Number 840001; 🇺🇸 Saint Louis, Missouri, United States

Investigational Site Number 840004; 🇺🇸 Cincinnati, Ohio, United States

Investigational Site Number 840005; 🇺🇸 Philadelphia, Pennsylvania, United States

Investigational Site Number 840006; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 840008; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 056001; 🇧🇪 Bruxelles, Belgium

Investigational Site Number 056002; 🇧🇪 Gent, Belgium