deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT03459859

Pevonedistat and Low Dose Cytarabine in Adult Patients With AML and MDS

An Open-Label, Dose Escalation, Phase 1 Study of PEVONEDISTAT, a Novel Inhibitor of the NEDD8-Activating Enzyme (NAE), in Combination With Low Dose Cytarabine (LDAC) in Adult Patients With Acute Myelogenous Leukemia (AML) and Advanced Myelodysplastic Syndromes (MDS)

Sponsor: Justin Watts, MD

Updated 12 times since 2018 Last updated: Dec 7, 2021 Started: May 21, 2018 Primary completion: Jun 25, 2021 Completion: Jun 25, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on AML and Acute Myelogenous Leukemia, this trial is completed. The trial is conducted by Justin Watts, MD and has accumulated 12 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotNot Yet Recruiting~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotNot Yet Recruiting~Jul 2018 – ~Feb 2019 · 7 months · monthly snapshotRecruiting~Feb 2019 – ~Aug 2019 · 6 months · monthly snapshotRecruiting~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshotRecruiting~Feb 2020 – ~Aug 2020 · 6 months · monthly snapshotRecruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshotRecruiting~Jan 2022 – ~Jul 2024 · 30 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2022 — Jul 2024 [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

  4. Sep 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  5. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

Show 7 earlier versions
  1. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  2. Feb 2020 — Aug 2020 [monthly]

    Recruiting PHASE1

  3. Aug 2019 — Feb 2020 [monthly]

    Recruiting PHASE1

  4. Feb 2019 — Aug 2019 [monthly]

    Recruiting PHASE1

  5. Jul 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  6. Jun 2018 — Jul 2018 [monthly]

    Not Yet Recruiting PHASE1

  7. Mar 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Justin Watts, MD
  • Takeda
Data source: University of Miami

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations