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NCT03594955 · ClinicalTrials.gov registry record · Phase 1
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03594955: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT03594955 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594955, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Primary Objective: * Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL), and determine the recommended phase 2 dose (RP2D) for the subsequent Expansion part. * Expansion part: To assess the activity of single agent SAR440234 at the RP2D in participants with R/R AML or HR-MDS. Secondary Objective: * To characterize the safety profile including cumulative adverse drug reactions. * To evaluate the potential immunogenicity of SAR440234. * To assess any preliminary evidence of hematologic response in the Dose Escalation Part.
Primary Outcome
DLTs: occurrence of any of following related to investigational medicinal product (IMP): Any grade (G) greater than or equal to (\>=) 3 nonhematological adverse events (AE); G4 hematological toxicities (bone marrow hypocellularity, decreased neutrophils, febrile neutropenia, decreased platelet count and anemia) as defined in national cancer institute common terminology criteria for adverse events (NCI-CTCAE, v4.03); G3 or G4 cytokine release syndrome (CRS) (G1: fever, nausea, fatigue, headache,
Interventions
- DRUG SAR440234
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2021-02-06 |
| Phase | Phase 1 |
Why NCT03594955 stopped before completion
NCT03594955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which SAR440234 is the first listed.
NCT03594955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03594955 about?
NCT03594955 is a clinical study titled "First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome". Primary Objective: * Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL), ...
What is the current status of trial NCT03594955?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2018-10-24. Estimated completion is 2021-02-06.
What interventions are being tested in trial NCT03594955?
The interventions under investigation include: SAR440234 (DRUG).
Who is sponsoring clinical trial NCT03594955?
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 NCT03594955's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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