Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01836705
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2013-04-17
Brief Title:
Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
Sponsor:
Sanofi
Organization:
Sanofi
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 PharmacokineticPharmacodynamic 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 PharmacokineticPharmacodynamic 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1115-7323 | OTHER | UTN | None |
| 2012-005642-38 | EUDRACT_NUMBER | None | None |