Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Conditions
Interventions
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 agen
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Exclusion criteria
Exclusion criteria: Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed