NTX-301 for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, ALAcute Myeloid Leukemia+2 MoreNTX-301 - Drug
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is testing a new drug, NTX-301, to see if it can help people with myeloid malignancies (a type of cancer). The drug is taken orally, and has shown promise in earlier studies.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 3 years

3 years
Efficacy: Clinical Benefit Rate (CBR)
Efficacy: Overall response rate (ORR)
Efficacy: Overall survival (OS)
Efficacy: Progression free survival (PFS)
Pharmacodynamics (PD): Global methylation (assay) in blood and/or marrow leukemia samples
Pharmacokinetics (PK): Area under the curve (AUC)
Pharmacokinetics (PK): Half life (t1/2)
Pharmacokinetics (PK): Maximum plasma concentration (Cmax)
Pharmacokinetics (PK): Time to reach maximum concentration (Tmax)
Safety/tolerability: Incidence of treatment related adverse events (AEs) and dose-limiting toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

NTX-301
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: NTX-301 · No Placebo Group · Phase 1

NTX-301
Drug
Experimental Group · 1 Intervention: NTX-301 · Intervention Types: Drug

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,446 Previous Clinical Trials
2,235,586 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

Has NTX-301 been granted clearance from the FDA?

"There is scant evidence regarding the security of NTX-301, so it earned a score of 1." - Anonymous Online Contributor

Unverified Answer

Has recruitment for this clinical trial commenced?

"According to clinicaltrials.gov, this medical study is now in the process of enrolling participants. This research initiative was first published on June 1st 2021 and had its most recent update on December 6th 2021." - Anonymous Online Contributor

Unverified Answer

What is the estimated sample size for this clinical research?

"Affirmative, clinicaltrials.gov reflects that this research is actively seeking volunteers. It was initially made available on January 6th 2021 and the most recent update occurred on December 6th 2021. This study requires 20 participants from a single medical centre to be recruited." - 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.