Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01156870
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2010-07-02
Brief Title:
First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Dose Escalation Safety and Pharmacokinetic First in Man Study of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2017-05
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 determine the maximum tolerated dose MTD of SAR566658
Secondary Objectives
To characterize the safety profile of SAR566658
To evaluate the pharmacokinetic profile of SAR566658
To assess the potential immunogenicity of SAR566658
To assess preliminary antitumor activity
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
To assess safety in the alternative schedules of SAR566658 administration
To determine the maximum tolerated dose MTD of SAR566658
Secondary Objectives
To characterize the safety profile of SAR566658
To evaluate the pharmacokinetic profile of SAR566658
To assess the potential immunogenicity of SAR566658
To assess preliminary antitumor activity
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
To assess safety in the alternative schedules of SAR566658 administration
Detailed Description:
The duration of the study for one patient in the dose escalation phase of the study will include a screening period of up to 3 weeks a 3-week treatment cycles and a 2-week treatment cycles The patients may continue treatment until disease progression unacceptable toxicity or willingness to stop followed by a minimum of 30-day follow-up If a patient treated in dose escalation part or in an expansion cohorts continues to benefit from the treatment at the time of Clinical Study Report the patient can continue study treatment and will continue to undergo all assessments as per the study flowchart Such patients will be followed at least until 30 days after the last IMP administration
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 |
|---|---|---|---|
| U1111-1116-4129 | OTHER | UTN | None |