Overview

This trial is active, not recruiting.

Condition wild-type ras metastatic colorectal cancer
Treatment observational
Sponsor Amgen
Start date December 2012
End date November 2016
Trial size 242 participants
Trial identifier NCT01732783, 20120100

Summary

This is a multicenter, observational prospective cohort study in France and Germany. Treatment centres with a focus on treating subjects with mCRC will be prospectively defined for potential inclusion in the study. Eligible subjects will be enrolled and have retrospective data collected from Baseline up to the point of enrolment. All subsequent chemotherapy cycles and Vectibix® doses will be recorded prospectively. Each subject will have data collected until approximately 30 days after the end of Vectibix® treatment, death, withdrawal of consent, loss to follow-up or up to 12 months from the first dose of Vectibix®, whichever occurs first.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Wild-type RAS confirmed
observational
Observational of the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer

Primary Outcomes

Measure
Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC
time frame: 12 months

Secondary Outcomes

Measure
Healthcare resource utilization
time frame: 12 months
Demography of disease population
time frame: 12 months
Response to Vectibix®
time frame: 12 months
Planned anti-cancer treatment initiated post Vectibix
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Subject is ≥ 18 years of age at date of enrolment - Histologically or cytologically confirmed carcinoma of colon or rectum - Subject with metastatic carcinoma of colon or rectum - Confirmed wild-type RAS status of tumour - Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available - Tumour assessment (ie, CT/MRI) within 12 weeks (84 days) prior to first Vectibix® infusion. - Subjects treated with at least one infusion of Vectibix® in combination with chemotherapy a maximum of 84 days before entering study: first-line in combination with FOLFOX or second-line in combination with FOLFIRI in subjects who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for treatment of wild-type RAS mCRC per approved prescribing information - Subject or subject's legally acceptable representative has provided informed consent (for countries where required per local regulations) - Subjects treated with Vectibix® in accordance with the current version of the SmPC Exclusion Criteria - Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency for any indication - Ongoing or planned concurrent participation in any clinical study where the dosing of Vectibix® is determined by the protocol (participation in clinical trials on an approved drug and observational trials are permitted but these cannot mandate how mCRC should be treated)

Additional Information

Official title Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Amgen.