SNDX-5613 for Acute Leukemias

Phase-Based Progress Estimates
Sir Charles Gairdner Hospital, Nedlands, AustraliaAcute Leukemias+4 MoreSNDX-5613 - Drug
Any Age
All Sexes
What conditions do you have?

Study Summary

This trial is to test a new cancer drug to see what dose is best and if it is effective and safe.

Eligible Conditions
  • Acute Leukemias of Ambiguous Lineage
  • Acute Myeloid Leukemia
  • Mixed Lineage Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Mixed Phenotype Acute Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

16 Primary · 14 Secondary · Reporting Duration: Approximately 5 years

Approximately 1 year
AUC0-24 (Phase 1)
AUC0-t (Phase 1)
CL/F (Phase 1)
Cmax (Phase 1)
Frequency, duration, and severity of serious adverse events (SAEs) (Phase 1)
Frequency, duration, and severity of treatment-emergent adverse events (TEAEs) (Phase 1)
Frequency, duration, and severity of treatment-related TEAEs (TRAEs) (Phase 1)
Occurrence of dose-limiting toxicities (DLTs) (Phase 1)
Tmax (Phase 1)
Vz/F (Phase 1)
t1/2 (Phase 1)
Approximately 19 months
Complete remission with partial hematologic recovery (CR+CRh) rate after 4 weeks of therapy (Phase 2)
Approximately 3 years
AUC0-24 (Phase 2)
AUC0-t (Phase 2)
BORR (CRc+ partial remission [PR]). (Phase 2)
CL/F (Phase 2)
Cmax (Phase 2)
Complete remission (CR) rate (Phase 2)
Composite definition of complete remission (CRc) Rate (Phase 2)
DOR (Phase 2)
Frequency and severity of adverse events (AEs) (Phase 2)
Frequency and severity of serious adverse events (SAEs) (Phase 2)
Frequency, duration, and severity of treatment-emergent adverse events (TEAEs) (Phase 2)
Frequency, duration, and severity of treatment-related TEAEs (TRAEs) (Phase 2)
Median RFS (Phase 2)
Tmax (Phase 2)
Vz/F (Phase 2)
t1/2 (Phase 2)
Approximately 34 months
TTR (Phase 2)
Approximately 5 years
OS (Phase 2)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Experimental: SNDX-5613
1 of 1

Experimental Treatment

440 Total Participants · 1 Treatment Group

Primary Treatment: SNDX-5613 · No Placebo Group · Phase 1 & 2

Experimental: SNDX-5613Experimental Group · 2 Interventions: SNDX-5613, cobicistat · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 5 years

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
41 Previous Clinical Trials
2,096 Total Patients Enrolled
Galit Rosen, M.D.Study DirectorSyndax Pharmaceuticals, Inc.
Nicole McNeer, M.D.Study DirectorSyndax Pharmaceuticals
1 Previous Clinical Trials
54 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a certain type of relapsed or refractory leukemia or lymphoma and specific genetic mutations. Your white blood cell count is below a certain level, and any previous treatment-related side effects have resolved or are mild. You have not received certain types of radiation, stem cell infusion, immunotherapy or biologics for a certain period of time. Your organs are functioning well, and if you can have children, you agree to use reliable birth control during the study.

Frequently Asked Questions

What are we hoping to learn from this experiment?

"The primary purpose of this one year long clinical trial is to evaluate the frequency and severity of adverse events. Additionally, the study will also focus on secondary objectives such as duration of response, apparent volume of distribution, and best overall remission rate." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial widely available in Canada?

"Patients are able to enroll at Memorial Sloan Kettering Cancer Center in New York, The Hospital for Sick Children in Toronto, and Stanford Cancer Institute in Palo Alto among 16 other hospitals." - Anonymous Online Contributor

Unverified Answer

What is the maximum number of patients that can join this trial?

"Yes, as of today, this clinical trial is recruiting patients. This experiment was originally posted on November 5th, 2019 and the most recent update was on July 28th, 2022. There are 440 total participants being recruited from 16 different locations." - Anonymous Online Contributor

Unverified Answer

Are there opportunities for new patients to join this experiment?

"The trial, which was posted on November 5th 2019 and updated most recently on July 28th 2022, is looking for participants. This information comes from the website." - Anonymous Online Contributor

Unverified Answer

Could you please provide more context on SNDX-5613 research?

"SNDX-5613 was first studied 18 years ago at University of Zurich. Since then, there have been 90 completed trials with 9 more currently underway. The majority of these ongoing studies are based in New York City." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.