Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01836705
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2013-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
\- 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: