deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT04034355

Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer (POLAR-A)

A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in the Adjuvant Treatment of Patients With Stage III or High-risk Stage II Colorectal Cancer

Sponsor: Egetis Therapeutics

Updated 12 times since 2019 Last updated: Nov 19, 2021 Started: Jan 7, 2019 Primary completion: Aug 31, 2020 Completion: Aug 31, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

On 01 March 2020, the Sponsor decided to place recruitment and dosing of patients on hold following interactions with the French regulatory authority, ANSM and the US clinical hold of another study (POLAR-M).

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This PHASE3 trial investigates Chemotherapy-induced Peripheral Neuropathy and Colorectal Cancer and is currently terminated or withdrawn. Egetis Therapeutics leads this study, which shows 12 recorded versions since 2019 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Aug 2019 – ~Dec 2019 · 4 months · monthly snapshotRecruiting~Dec 2019 – ~Mar 2020 · 3 months · monthly snapshotRecruiting~Mar 2020 – ~Jun 2020 · 3 months · monthly snapshotActive Not Recruiting~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshotActive Not Recruiting~Aug 2020 – ~Nov 2020 · 3 months · monthly snapshotActive Not Recruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Feb 2022 · 4 months · monthly snapshotCompleted~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 11 months · monthly snapshotTerminated

Change History

12 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Feb 2022 — Jul 2024 [monthly]

    Terminated PHASE3

    Status: CompletedTerminated

  5. Oct 2021 — Feb 2022 [monthly]

    Completed PHASE3

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

    Completed PHASE3

  2. Nov 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  3. Aug 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  5. Mar 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  6. Dec 2019 — Mar 2020 [monthly]

    Recruiting PHASE3

  7. Aug 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

    First recorded

Jan 2019

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Egetis Therapeutics
  • Solasia Pharma K.K.
Data source: Egetis Therapeutics

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