WHO ICTRP trial

An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic…

EUCTR2009-013317-10-BE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2009-013317-10-BE
Public title An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHN
Scientific title An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCHN
Primary sponsor Genmab A/S
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Hungary;Slovakia;Belgium;United Kingdom
Conditions Non-Curable Squamous cell carcinoma of the head and neck (SCCHN) MedDRA version: 12.0 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck
Interventions Product Name: HuMax-EGFr (zalutumumab) Product Code: HuMax-EGFr Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: zalutumumab CAS Number: 667901-13-5 Current Sponsor code: HuMax-EGFr Concentration unit: mg/ml…
Registration date Apr 9, 2009
Target size 26
Secondary IDs GEN211
Registry page clinicaltrialsregister.eu

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