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)
NCT ID: NCT02089737
Last Updated: 2017-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
3091 participants
OBSERVATIONAL
2010-06-30
2012-07-31
Brief Summary
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Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Panitumumab 6 mg/kg
Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks
Panitumumab
Panitumumab for intravenous infusion
Interventions
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Panitumumab
Panitumumab for intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Postmarketing Group Manager
Role: STUDY_CHAIR
Takeda
Other Identifiers
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JapicCTI-132374
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-R140654
Identifier Type: REGISTRY
Identifier Source: secondary_id
183-011
Identifier Type: -
Identifier Source: org_study_id
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