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NCT01156870 · ClinicalTrials.gov registry record · Phase 1
First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
NCT01156870 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 114 participants.
The verdict
NCT01156870, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
Study 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
Interventions
- DRUG SAR566658
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2010-09-08 |
| Est. Completion | 2017-04-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01156870
The ClinicalTrials.gov registry entry for NCT01156870 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SAR566658 is the first listed.
NCT01156870 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01156870 about?
NCT01156870 is a clinical study titled "First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor". 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 acti...
What is the current status of trial NCT01156870?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2010-09-08. Estimated completion is 2017-04-07.
What interventions are being tested in trial NCT01156870?
The interventions under investigation include: SAR566658 (DRUG).
Who is sponsoring clinical trial NCT01156870?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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