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)

Completed

• Conditions: Advanced or Recurrent Colorectal Cancer
• Interventions: Drug: Panitumumab

• Registration Number: NCT02089737
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-18
• Results First Submitted: 2015-04-20
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Results First Posted: 2017-04-06
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3091

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	Baseline through Week 42	The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Up to Week 42 or death (whichever occurred first)	Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Overall Survival	Up to Week 42 or death (whichever occurred first)	Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.