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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of 6 months

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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What illnesses are S 64315 (also referred as MIK665) and azacitidine typically prescribed for?

"S 64315 (also known as MIK665) and azacitidine are both frequently utilized to treat malignant neoplasms. Additionally, they can be employed to address diseases such as anemia, 20-30% blasts in the peripheral blood, neutropenia or thrombocytopenia."

Answered by AI

Are there any current opportunities for volunteers to participate in this investigation?

"Per the records maintained on clinicaltrials.gov, this trial is recruiting patients and was first made available on February 17th 2021 before its most recent update in August of 2022."

Answered by AI

Have researchers conducted experiments involving S 64315 (MIK665) and azacitidine in the past?

"Currently, 173 investigations on S 64315 (also known as MIK665) and azacitidine are ongoing with 32 of them in the final phase. Although many trials take place in Saint Louis, Missouri there is an impressive total of 5664 centers that are conducting research for these drugs."

Answered by AI

What is the upper limit of individuals that can participate in this research?

"Affirmative. Clinicaltrials.gov reveals that this research is presently recruiting participants, having been first posted on February 17th 2021 and most recently revised on August 3rd 2022. There are 180 available slots across one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

2021. "Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04629443.