- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01075841
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The PMS study is planned to be conducted within 6 years from the approval date of the new indication in approximately 50 institutions in Korea.
OBJECTIVES
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with recurrent and/or metastatic SCCHN in terms of frequency and severity of adverse events (AEs)
Secondary objectives:
- To gather clinical efficacy information of the treatment
During the PMS period, each subject's background, subject's medical history (surgery, anti-cancer treatment), Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all AEs (regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected. The PMS will be based on all cases treated with Erbitux at least once.
Erbitux will be prescribed to recurrent and/or metastatic SCCHN subjects according to the approved national label as in routine clinical practice under the supervision of an investigator experienced in the use of antineoplastic medicinal products. Prior to the first infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered intravenously via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 10 mg/min, equivalent to 5 ml/min of Erbitux 2 mg/ml or 2ml/min of Erbitux 5mg/mL.
Studietype
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Safety
Tidsramme: After approval of new indication till 6 years of PMS period
|
Frequency and severity of all adverse events (AEs), regardless of the causal relationship to Erbitux
|
After approval of new indication till 6 years of PMS period
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Efficacy
Tidsramme: Throughout 6 years of PMS period
|
Best tumour response; time to progression; and duration of tumor response
|
Throughout 6 years of PMS period
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EMR 62241-510
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