Spots Global Cancer Trial Database for Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
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Trial Identification
Brief Title: Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
Official Title: Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors
Study ID: NCT01836705
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, St 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
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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