deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT02822482

Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss (COPAN-ORL06)

Phase ib/II Trial of Copanlisib, a Selective PI3K Inhibitor, in Combination With Cetuximab in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss.

Sponsor: UNICANCER

Updated 7 times since 2017 Last updated: Mar 24, 2021 Started: Jun 30, 2016 Primary completion: Oct 9, 2019 Completion: Oct 9, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

futilty of the treatment

A PHASE1/PHASE2 clinical study on Carcinoma, Squamous Cell of Head and Neck, this trial is terminated or withdrawn. The trial is conducted by UNICANCER and has accumulated 7 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotRecruiting~Jun 2018 – ~May 2019 · 11 months · monthly snapshotRecruiting~May 2019 – ~Jan 2021 · 20 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshotActive Not Recruiting~Apr 2021 – ~Jul 2024 · 39 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Apr 2021 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

    Status: Active Not RecruitingTerminated

  4. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. May 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

Show 2 earlier versions
  1. Jun 2018 — May 2019 [monthly]

    Recruiting PHASE1_PHASE2

  2. Jan 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Jun 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • UNICANCER
Data source: UNICANCER

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