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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 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 7 participants.
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.
Interventions
- DRUG SAR440234
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2021-02-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03594955
The ClinicalTrials.gov registry entry for NCT03594955 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 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 SAR440234 is the first listed.
NCT03594955 reports 0 study locations.
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.
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