NCT01836705

Effect of SAR302503 on ECG Activity in Patients With Solid Tumors

Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2013-04-22
• Last updated: 2025-03-05

Locations

10 sites across 2 countries: United States, Belgium