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NCT02187848 · ClinicalTrials.gov registry record · Phase 1
Evaluation of SAR408701 in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 254
- Enrollment target
NCT02187848 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 254 participants.
The verdict
NCT02187848, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 254 participants
- Enrollment target
Study Summary
Primary Objectives: * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W). * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle). * To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1. Secondary Objectives: * To characterize the overall safety profile of SAR408701. * To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives. * To identify the recommended phase 2 dose (RP2D) of SAR408701. * To assess the potential immunogenicity of SAR408701.
Interventions
- DRUG SAR408701
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2014-07-23 |
| Est. Completion | 2024-11-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02187848
The ClinicalTrials.gov registry entry for NCT02187848 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 254 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 SAR408701 is the first listed.
NCT02187848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02187848 about?
NCT02187848 is a clinical study titled "Evaluation of SAR408701 in Patients With Advanced Solid Tumors". Primary Objectives: * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W). * To determine the maximum tolerate...
What is the current status of trial NCT02187848?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 254 participants. The study started on 2014-07-23. Estimated completion is 2024-11-19.
What interventions are being tested in trial NCT02187848?
The interventions under investigation include: SAR408701 (DRUG).
Who is sponsoring clinical trial NCT02187848?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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