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Trial record 1 of 1 for:    183-011
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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02089737
First received: March 13, 2014
Last updated: February 21, 2017
Last verified: February 2017
  Purpose

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.


Condition Intervention
Advanced or Recurrent Colorectal Cancer Drug: Panitumumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants With Adverse Drug Reactions [ Time Frame: 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:
  • Progression-free Survival [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 3091
Study Start Date: June 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Panitumumab 6 mg/kg
Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks
Drug: Panitumumab
Panitumumab for intravenous infusion
Other Name: Vectibix

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089737

Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02089737     History of Changes
Other Study ID Numbers: 183-011
JapicCTI-132374 ( Registry Identifier: JapicCTI )
JapicCTI-R140654 ( Registry Identifier: JapicCTI )
Study First Received: March 13, 2014
Results First Received: April 20, 2015
Last Updated: February 21, 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017