deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT04176393

A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation

A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation

Sponsor: CStone Pharmaceuticals

Interventions ivosidenib
Updated 7 times since 2019 Last updated: Feb 10, 2023 Started: Nov 12, 2019 Primary completion: Feb 18, 2021 Completion: Jan 18, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Relapsed or Refractory Acute Myeloid Leukemia and is currently completed. CStone Pharmaceuticals leads this study, which shows 7 recorded versions since 2019 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshotActive Not Recruiting~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshotActive Not Recruiting~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

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

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  4. Sep 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2021 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

Show 2 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  2. Dec 2019 — Jan 2021 [monthly]

    Recruiting PHASE1

    First recorded

Nov 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • CStone Pharmaceuticals
Data source: CStone Pharmaceuticals

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

Study Locations