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)

• ClinicalTrials.gov Identifier: NCT02089737
• Recruitment Status: Completed
• First Posted: March 18, 2014
• Results First Posted: April 6, 2017
• Last Update Posted: April 6, 2017
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

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.

Condition or disease	Intervention/treatment
Advanced or Recurrent Colorectal Cancer	Drug: Panitumumab

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 Design

• Study Type: Observational
• Actual Enrollment: 3091 participants
• 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)
• Study Start Date: June 2010
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: July 2012

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

Sponsors and Collaborators

Takeda

Investigators

• Study Chair: Postmarketing Group Manager; Takeda

More Information

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02089737
• Other Study ID Numbers: 183-011; JapicCTI-132374 ( Registry Identifier: JapicCTI ); JapicCTI-R140654 ( Registry Identifier: JapicCTI )
• First Posted: March 18, 2014
• Results First Posted: April 6, 2017
• Last Update Posted: April 6, 2017
• Last Verified: February 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; Panitumumab; Antineoplastic Agents, Immunological; Antineoplastic Agents