Clinical trial · Observational
A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck
A Korean Post-Marketing Surveillance Study On Erbitux (Cetuximab) In Patients With Recurrent And/Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After loss of orphan drug status in Korea, study was withdrawn due to Regulatory Authority request. Patients will be enrolled into NCT01075828 instead.
Summary
Brief summary (as posted)
This is a prospective post-marketing surveillance (PMS) study to collect safety information from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, there is a requirement to investigate more than 600 subjects during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Squamous Cell | Squamous Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety
- timeFrame
- After approval of new indication till 6 years of PMS period
- description
- Frequency and severity of all adverse events (AEs), regardless of the causal relationship to Erbitux
Secondary outcomes (1)
- measure
- Efficacy
- timeFrame
- Throughout 6 years of PMS period
- description
- Best tumour response; time to progression; and duration of tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux. The national label approved by Korea Food \& Drug Administration is "Erbitux in combination with radiation therapy is indicated for the treatment of subjects with metastatic/recurrent SCCHN.
References
Publications (0)
Data not yet available