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NCT01391533 · ClinicalTrials.gov registry record · Phase 1
Study of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01391533 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 72 participants.
The verdict
NCT01391533, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of SAR125844 when administered as single agent at the MTD. To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer \[NSCLC\] patients) and in patients with Phospho-MET positive tumors without MET-gene amplification. Secondary Objectives: To characterize the global safety profile including cumulative toxicities. To evaluate the pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s). To assess preliminary antitumor activity in patients with measurable/evaluable disease, according to RECIST 1.1 criteria. To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study, in the escalation part only. To evaluate other pharmacodynamic biomarkers and help selection of patients who could benefit from SAR125844. To explore MET-gene amplification status in circulating DNA.
Interventions
- DRUG SAR125844
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01391533
The ClinicalTrials.gov registry entry for NCT01391533 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 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 SAR125844 is the first listed.
NCT01391533 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01391533 about?
NCT01391533 is a clinical study titled "Study of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors". Primary Objectives: To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of SAR125844 when administered as single agent at the MTD. To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene amplified solid tumors (including sub-group of...
What is the current status of trial NCT01391533?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2011-07. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01391533?
The interventions under investigation include: SAR125844 (DRUG).
Who is sponsoring clinical trial NCT01391533?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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