NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Date of first enrollment	11/12/2013
Target sample size	2000
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Vectibix (panitumumab) for Intravenous Infusion 100 mg and 400 mg INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient's condition.

Outcome(s)

Primary Outcome	Frequency of adverse drug reactions Primary timeframe 42 weeks The frequency of adverse drug reactions will be tabulated by type, seriousness, time of onset, etc. Specifically, information will be collected on the development of the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.
Secondary Outcome	Progression free survival and overall survival Secondary timeframe 42 weeks The time to progression or the time to death from the start of panitumumab administration will be tabulated.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Exclude criteria	Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix