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NCT01436565 · ClinicalTrials.gov registry record · Phase 1
A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01436565 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 26 participants.
The verdict
NCT01436565, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors. Secondary Objectives: * To characterize the global safety profile of SAR245408 in combination with SAR256212 * To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination * To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only) * To determine the immunogenicity of SAR256212 as administered with SAR245408
Interventions
- DRUG MM-121 (SAR256212)
- DRUG SAR245408
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01436565
The ClinicalTrials.gov registry entry for NCT01436565 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 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 2 interventions - of which MM-121 (SAR256212) is the first listed.
NCT01436565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01436565 about?
NCT01436565 is a clinical study titled "A Study of Investigational SAR256212 in Combination With SAR245408 in Patients With Solid Tumor Cancers". Primary Objective: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors. Secondary Objectives: * To characterize the global safety profile of S...
What is the current status of trial NCT01436565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2011-11. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01436565?
The interventions under investigation include: MM-121 (SAR256212) (DRUG), SAR245408 (DRUG).
Who is sponsoring clinical trial NCT01436565?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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