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

Amgen

Status: Completed

Conditions: Metastatic Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02322736

20120286

Details and patient eligibility

About

The study will shed additional light on the impact of Vectibix® under the current, standard clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the outcomes of Vectibix® treatment in real-life setting.

Full description

This is a single-arm, multi-center, prospective, observational, descriptive, noninterventional study in patients with mCRC in Greece who receive Vectibix®in 1st or 2nd line according to approved indication. The aim of the study is to obtain a clear understanding of the current practices concerning real-life treatment of mCRC patients with Vectibix® in first-line in combination with chemotherapy or second-line in combination with chemotherapy in Greece. This setting will also provide the opportunity to observe in a non-selected patient population with RAS WT mCRC the real-life habits of mCRC treatment, and in particular the duration and the outcomes of Vectibix® treatment. The data generated by this study may be used for reimbursement purposes, as it becomes an increasingly common need in Greece to provide locally generated data for use of drugs in the real-life setting to regulatory agencies and/or payors. Furthermore, this study could address the existing data gap in the treatment of anti-EGFR therapy beyond progression in the real-life setting.

Primary Objective(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.

Secondary Objective(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®.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

218 participants in 1 patient group

WT RAS mCRC

Description:

Wild Type RAS metastatic colorectal cancer patients