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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: Completed Phase 1 study, sponsored by Sanofi.
NCT01436565 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01436565 record still lists
NCT01436565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which MM-121 (SAR256212) is the first listed.
NCT01436565 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01436565's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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