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NCT03813147 · ClinicalTrials.gov registry record · Phase 1

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT03813147: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT03813147 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03813147, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or has not responded to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, fludarabine phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and pevonedistat may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

Interventions

  • DRUG Azacitidine
  • DRUG Cytarabine
  • DRUG Fludarabine Phosphate
  • DRUG Methotrexate
  • DRUG Pevonedistat

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2019-05-17
Est. Completion 2023-12-31
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03813147

The ClinicalTrials.gov registry entry for NCT03813147 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Azacitidine is the first listed.

NCT03813147 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03813147 about?

NCT03813147 is a clinical study titled "Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome". This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or has not responded to treatment (refractory). Pevonedistat may s...

What is the current status of trial NCT03813147?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-05-17. Estimated completion is 2023-12-31.

What interventions are being tested in trial NCT03813147?

The interventions under investigation include: Azacitidine (DRUG), Cytarabine (DRUG), Fludarabine Phosphate (DRUG), Methotrexate (DRUG), Pevonedistat (DRUG).

Who is sponsoring clinical trial NCT03813147?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.