← Back to Search

Mcl-1 inhibitor

S 64315 (also referred as MIK665) and venetoclax for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Andrew WEI

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 months.

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat leukemia. The goal is to find out what dose is safe and how well it works.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 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 intensity

Incidence and severity of AEs

Incidence and severity of SAEs

+3 more

Secondary outcome measures

Anti-leukemic activity

Pharmacokinetic profile of S64315 administered in combination with Venetoclax in plasma: Area Under the Curve (AUC)

Pharmacokinetic profile of S64315 administered in combination with Venetoclax in plasma: Concentration at the end of infusion (Cinf)

+1 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Initial Schedule - S64315 medium dose and venetoclax medium dose administered in combinationExperimental Treatment1 Intervention

Group II: Initial Schedule - S64315 medium dose and venetoclax low dose administered in combinationExperimental Treatment1 Intervention

Group III: Initial Schedule - S64315 medium dose and venetoclax high dose administered in combinationExperimental Treatment1 Intervention

Group IV: Initial Schedule - S64315 low dose and venetoclax high dose administered in combinationExperimental Treatment1 Intervention

Group V: Initial Schedule - S64315 high dose and venetoclax medium dose administered in combinationExperimental Treatment1 Intervention

Group VI: Alternative Schedule - Venetoclax medium dose administered with no S64315Experimental Treatment1 Intervention

Group VII: Alternative Schedule - S64315 medium dose and venetoclax medium dose administered in combinationExperimental Treatment1 Intervention

Group VIII: Alternative Schedule - S64315 high dose and venetoclax low dose administered in combinationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

S 64315 (also referred as MIK665) and venetoclax

2018

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor

86 Previous Clinical Trials

67,099 Total Patients Enrolled

ADIR, a Servier Group companyIndustry Sponsor

32 Previous Clinical Trials

4,379 Total Patients Enrolled

Andrew WEIPrincipal InvestigatorThe Alfred Hospital, Melbourne, Victoria

1 Previous Clinical Trials

38 Total Patients Enrolled

Frequently Asked Questions

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

How many people can potentially qualify for this clinical experiment?

"The recruitment for this trial has ended as of November 4th 2022. If you're seeking alternative trials, there are 1,554 research projects related to leukemia, myeloid acute and S 64315 (otherwise known as MIK665) along with 219 studies involving venetoclax that are currently searching for participants."

Answered by AI

Have the drugs S 64315 (MIK665) and venetoclax received official sanction from the Food & Drug Administration?

"With limited data on both safety and efficacy, the team at Power gave S 64315 (MIK665) and venetoclax a score of 1."

Answered by AI

Is the recruitment period for this trial still going on?

"Clinicaltrials.gov confirms that this medical study is not actively seeking out participants, as it was posted on November 28th 2018 and last updated Nov 4th 2022. Nonetheless, there are currently 1753 other trials with open recruitment slots available for those interested in volunteering their time and resources to the cause of scientific advancement."

Answered by AI

What precedent exists for the combined use of S 64315 (also referred as MIK665) and venetoclax in clinical studies?

"Currently, 219 clinical trials are investigating the efficacy of S 64315 (also referred as MIK665) and venetoclax. 28 of these studies have advanced to Phase 3. Boston, Massachusetts is home to most investigations into this treatment, with 7198 different sites conducting research on it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.

2018. "Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03672695.