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Anti-metabolites

S64315 + Azacitidine for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patients aged ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 6 months
Awards & highlights

Study Summary

This trial will study if a new combo of drugs is safe and works well against acute myeloid leukemia.

Who is the study for?
This trial is for adults with acute myeloid leukemia (AML) who haven't been treated before and can't have intensive chemo, or those whose AML has returned or didn’t respond to treatment. Participants need to be in fairly good health otherwise, with a performance status of ≤2 on the ECOG scale and proper organ function.Check my eligibility
What is being tested?
The trial is testing the combination of S64315 (MIK665) and azacitidine to see if they're safe together, how well patients tolerate them, and their effectiveness against AML. It's an early-phase study which means it’s partly about finding the right dose as well as checking for benefits.See study design
What are the potential side effects?
While specific side effects aren’t listed here, common ones from drugs like S64315 and azacitidine may include nausea, vomiting, fatigue, fever, low blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT) (Phase I - dose escalation)
Dose intensity (Phase I - dose escalation)
Incidence and severity of Adverse Events (AEs) (Phase I - dose escalation)
+3 more
Secondary outcome measures
Assess anti-leukemic activity of S64315 in combinaison with azacitidine (Phase I - dose escalation)
Pharmacokinetic profile of S64315 administered in combination with Azacitidine in plasma: Area Under the Curve (AUC) (Phase I - dose escalation)
Pharmacokinetic profile of S64315 administered in combination with Azacitidine in plasma: maximum Concentration (Cmax) (Phase I - dose escalation)

Trial Design

1Treatment groups
Experimental Treatment
Group I: S64315 (also referred as MIK665) with azacitidineExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,399 Total Patients Enrolled
Institut de Recherches Internationales ServierLead Sponsor
86 Previous Clinical Trials
67,119 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04629443 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: S64315 (also referred as MIK665) with azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04629443 — Phase 1 & 2
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629443 — Phase 1 & 2
~4 spots leftby Jun 2025
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