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Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01732783
First received: November 20, 2012
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Wild-type RAS Metastatic Colorectal Cancer
Other: Observational
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC [ Time Frame: 12 months ]
    Type of chemotherapy combined with Vectibix® Starting dose and administration schedule of Vectibix® and chemotherapy Cumulative dose, maximum dose, duration of exposure and total number of infusions received of Vectibix® therapy and chemotherapy Dose alterations (including changes in frequency, reductions and/or delays) and reason(s) for dose alterations of Vectibix® and/or concomitant chemotherapy Discontinuation and reason(s) for discontinuation of Vectibix® and chemotherapy


Secondary Outcome Measures:
  • Healthcare resource utilization [ Time Frame: 12 months ]
    Including type of visit and reason for hospitalisation

  • Demography of disease population [ Time Frame: 12 months ]
    Demographics, disease characteristics, co-morbidities, individual treatment goals and prior treatment history

  • Response to Vectibix® [ Time Frame: 12 months ]
    including best response, conversion to resectability, and by individual treatment goals

  • Planned anti-cancer treatment initiated post Vectibix [ Time Frame: 12 months ]
    Summaries of planned anti-cancer treatment initiated post Vectibix® discontinuation


Enrollment: 242
Study Start Date: December 2012
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metastatic Colorectal Cancer
Wild-type RAS confirmed
Other: Observational
Observational of the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All treatment centres (inpatient and outpatient) with a focus on treating subjects with mCRC. Centres will be selected to represent academic, oncology and specialist settings and to provide geographical diversity in France and Germany.
Criteria

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)
  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: NCT01732783

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01732783     History of Changes
Other Study ID Numbers: 20120100
Study First Received: November 20, 2012
Last Updated: December 7, 2016

Keywords provided by Amgen:
Wild-type RAS
Metastatic Colorectal Cancer
Vectibix

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

ClinicalTrials.gov processed this record on May 25, 2017