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NCT02089737 Clinical Trial

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)

Advanced or Recurrent Colorectal Cancer Clinical Trial

Official title:
Vectibix 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02089737
Other study ID # 183-011
Secondary ID
Status Completed
Phase N/A
First received March 13, 2014
Last updated March 13, 2014
Start date June 2010
Est. completion date July 2012

Study information
Verified date March 2014
Source Takeda
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3091
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Panitumumab
Panitumumab for intravenous infusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of adverse drug reactions The frequency of adverse drug reactions by type, seriousness and time to 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. Baseline through Week 42 Yes
Secondary Existence or non-existence of progression free survival The time to progression from the start of panitumumab administration will be tabulated. Baseline through Week 42 No
Secondary Overall Survival The time to death from the start of panitumumab administration will be tabulated. Baseline through Week 42 No