deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT03602495

A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer (DTC)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Donafenib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Conditions Differentiated Thyroid Cancer
Interventions Donafenib Placebo
Updated 9 times since 2018 Last updated: Nov 29, 2021 Started: Aug 29, 2018 Primary completion: Feb 28, 2021 Completion: Jul 15, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Based on IDMC's recommendations during the interim analysisthe trial has reached the goal of early termination of the trial. the sponsor communicating with CDE, CDE agreed to unblind the trial and submit a NDA.

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Listed as NCT03602495, this PHASE3 trial focuses on Differentiated Thyroid Cancer and remains terminated or withdrawn. Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd, it has been updated 9 times since 2018, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshotRecruiting~Sep 2018 – ~Nov 2019 · 14 months · monthly snapshotRecruiting~Nov 2019 – ~Nov 2020 · 12 months · monthly snapshotRecruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~Jan 2022 · 3 months · monthly snapshotRecruiting~Jan 2022 – ~Jul 2024 · 30 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Jan 2022 — Jul 2024 [monthly]

    Terminated PHASE3

    Status: Recruiting → Terminated

  4. Oct 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  5. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

▶ Show 4 earlier versions

  1. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  2. Nov 2019 — Nov 2020 [monthly]

    Recruiting PHASE3

  3. Sep 2018 — Nov 2019 [monthly]

    Recruiting PHASE3

  4. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Data source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

Study Locations