Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01732783
First received: November 20, 2012
Last updated: January 22, 2014
Last verified: January 2014
  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
Wild-type KRAS Metastatic Colorectal Cancer
Other: Observational

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 KRAS 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 ] [ Designated as safety issue: No ]
    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 reductions and/or delays and reason(s) for of Vectibix® and/or chemotherapy Discontinuation and reason(s) for discontinuation of Vectibix® and chemotherapy


Secondary Outcome Measures:
  • Healthcare resource utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Including type of visit and reason for hospitalisation

  • Demography of disease population [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Demographics, disease characteristics, co-morbidities, individual treatment goals and prior treatment history

  • Response to Vectibix® [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    including best response, conversion to resectability, and by individual treatment goals

  • Planned anti-cancer treatment initiated post Vectibix [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Summaries of planned anti-cancer treatment initiated post Vectibix® discontinuation


Estimated Enrollment: 740
Study Start Date: December 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metastatic Colorectal Cancer
Wild-type KRAS confirmed
Other: Observational
Observational of the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type KRAS Metastatic Colorectal Cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 KRAS 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 42 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 KRAS mCRC per approved prescribing information
  • Subject or subject's legally acceptable representative has provided informed consent (for countries where required per local regulations)

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732783

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

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01732783     History of Changes
Other Study ID Numbers: 20120100
Study First Received: November 20, 2012
Last Updated: January 22, 2014
Health Authority: Germany: Paul-Ehrlich-Institut (PEI)
Germany: Kassenärztliche Bundesvereinigung (KBV)
Germany: Gesetzliche Krankenversicherung (GKV)
Germany: Ethik-Kommission der Bayerischen Landesärztekammer
Germany: Verband der Privaten Krankenversicherung e.V. (PKV)
France: Comite consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé (CCTIRS)
France: Commission nationale de l'informatique et des libertés (CNIL)
France: Conseil National de l'Ordre des Médecins (CNOM)

Keywords provided by Amgen:
Wild-type KRAS
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 April 22, 2014