Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02322736
• Date of registration: 19/12/2014
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR VISION
• Scientific title: A Prospective Observational Study of 1st and 2nd Line Vectibix® Use in KRAS/NRAS-wt mCRC Patients to Evaluate Pattern of Use and Overall Response Rates
• Date of first enrolment: November 21, 2014
• Target sample size: 218
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02322736
• Study type: Observational

Countries of recruitment

Greece

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patient (age =18 years) at enrollment

- Histological documentation of mCRC diagnosis

- RAS WT tumor documented before study enrolment as per routine laboratory finding

- Subjects whose care will be managed primarily by the enrolling physician and/or all
records will be available

- Measurable disease at baseline (preferably according to the Response Evaluation
Criteria in Solid Tumors version 1.1 (RECIST v1.1) if routinely used)

- Currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line
treatment regimen, including Vectibix® as per indication

- Tumor assessment (i.e. CT/MRI) within 16 weeks prior to first Vectibix® infusion

- Signed informed consent

Exclusion Criteria:

- Participation in any interventional clinical study (currently or during the three
previous months from enrollment).

- Compromised ability to give informed consent (defined per clinical judgment).

- Unknown or mutant RAS tumor type



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Colorectal Cancer

Primary Outcome(s)

To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication. [Time Frame: 42 months]

Secondary Outcome(s)

To investigate the rate of objective response (ORR, defined as either a Complete Response or a Partial Response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mCRC including Vectibix®. [Time Frame: 42 months]

Secondary ID(s)

20120286

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ZeinCRO Hellas SA