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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: Completed Phase 1 study, sponsored by Sanofi.
NCT01156870 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 114 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01156870 record still lists
NCT01156870 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 1 intervention - of which SAR566658 is the first listed.
NCT01156870 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01156870's enrollment target sits among peer trials
114 507th of 2000 higher than 1,493 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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