deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01415674

Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients (PREDICTOR)

Multi-centric Randomized Phase II Study of Pre-operative Afatinib (BIBW2992) Aiming at Identifying Predictive and Pharmacodynamic Biomarkers of Biological Activity and Efficacy in Untreated Non-metastatic Head and Neck Squamous Cell Carcinoma Patients

Sponsor: UNICANCER

Interventions Afatinib
Updated 11 times since 2017 Last updated: Feb 1, 2022 Started: Jan 31, 2012 Primary completion: Dec 31, 2021 Completion: Dec 31, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Carcinoma, Squamous Cell of Head and Neck, this trial is completed. The trial is conducted by UNICANCER and has accumulated 11 data snapshots since 2012. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Sep 2017 · 8 months · monthly snapshotActive Not Recruiting~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshotUnknown Status~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotUnknown Status~Jul 2018 – ~Nov 2019 · 16 months · monthly snapshotCompleted~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshotCompleted~Apr 2021 – ~Mar 2022 · 11 months · monthly snapshotActive Not Recruiting~Mar 2022 – ~Jul 2024 · 28 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

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

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Mar 2022 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  5. Apr 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: CompletedActive Not Recruiting

Show 6 earlier versions
  1. Jan 2021 — Apr 2021 [monthly]

    Completed PHASE2

  2. Nov 2019 — Jan 2021 [monthly]

    Completed PHASE2

  3. Jul 2018 — Nov 2019 [monthly]

    Completed PHASE2

    Status: Unknown StatusCompleted

  4. Jun 2018 — Jul 2018 [monthly]

    Unknown Status PHASE2

  5. Sep 2017 — Jun 2018 [monthly]

    Unknown Status PHASE2

    Status: Active Not RecruitingUnknown Status

  6. Jan 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Jan 2012

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 .