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Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

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Takeda

Status

Completed

Conditions

Advanced or Recurrent Colorectal Cancer

Treatments

Drug: Panitumumab

Study type

Observational

Funder types

Industry

Identifiers

NCT02089737
JapicCTI-132374 (Registry Identifier)
JapicCTI-R140654 (Registry Identifier)
183-011

Details and patient eligibility

About

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.

Full description

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients.

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.

Enrollment

3,091 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene

Exclusion criteria

  • Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix

Trial design

3,091 participants in 1 patient group

Panitumumab 6 mg/kg
Description:
Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks
Treatment:
Drug: Panitumumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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