Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03594955
Status:
TERMINATED
Last Update Posted:
2022-05-24
First Post:
2018-07-02
Brief Title:
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia Acute Lymphoid Leukemia and Myelodysplastic Syndrome
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Open-label First-in-human Dose Escalation Study of SAR440234 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia RR AML B-cell Acute Lymphoblastic Leukemia B-ALL or High Risk Myelodysplasia HR-MDS
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 RR 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 RR 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
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 RR 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 RR 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
Detailed Description:
The duration of the study for the participants included a period for screening of up to 14 days The cycle duration was 42 days Participants continued study treatment as long as clinical benefit was possible or until disease progression unacceptable adverse reaction participants decision to stop treatment or other reason of discontinuation After study treatment discontinuation participants returned to the study site 30 days after the last administration of SAR440234 for end of treatment assessments Participants without documented disease progression at the end of a treatment visit who had not yet started treatment with another anti-cancer therapy would proceed with monthly follow-up visits until initiation of another anti-cancer therapy disease progression or study cut-off date whichever came first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1197-8041 | OTHER | UTN | None |
| 2017-004148-39 | EUDRACT_NUMBER | None | None |