deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT03422536

Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma

A Randomized, Phase II Study of Ficlatuzumab With or Without Cetuximab in Patients With Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Sponsor: National Cancer Institute (NCI)

Conditions HNSCC Head and Neck Basaloid Carcinoma Head and Neck Cancer Oropharyngeal Cancer Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Squamous Cell Carcinoma of Unknown Primary Origin Stage IV Lip and Oral Cavity Squamous Cell Carcinoma Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma Stage IV Oropharyngeal Squamous Cell Carcinoma Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma Stage IVA Oropharyngeal Squamous Cell Carcinoma Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma Stage IVB Oropharyngeal Squamous Cell Carcinoma Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma Stage IVC Oropharyngeal Squamous Cell Carcinoma
Interventions Cetuximab Ficlatuzumab
Updated 19 times since 2018 Last updated: Aug 15, 2024 Started: Dec 5, 2017 Primary completion: Mar 29, 2022 Completion: Apr 5, 2022
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 HNSCC and Head and Neck Basaloid Carcinoma, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 19 data snapshots since 2017. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Jun 2019 · 10 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Oct 2019 · 3 months · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Jun 2020 · 7 months · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~May 2021 · 3 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshot~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshot~Sep 2022 – ~Apr 2023 · 7 months · monthly snapshot~Apr 2023 – ~Aug 2023 · 4 months · monthly snapshot~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – present · 21 months · monthly snapshot

Change History

19 versions recorded

  1. Oct 2024 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Oct 2024 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Apr 2023 — Aug 2023 [monthly]

    Completed PHASE2

▶ Show 14 earlier versions

  1. Sep 2022 — Apr 2023 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Apr 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2021 — Apr 2022 [monthly]

    Active Not Recruiting PHASE2

  4. May 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2

  5. Feb 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  6. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  7. Jun 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  8. Nov 2019 — Jun 2020 [monthly]

    Recruiting PHASE2

  9. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE2

  10. Jul 2019 — Oct 2019 [monthly]

    Recruiting PHASE2

  11. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE2

  12. Aug 2018 — Jun 2019 [monthly]

    Recruiting PHASE2

  13. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  14. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

    First recorded

Dec 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • University of Arizona
Data source: University of Arizona

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

Study Locations