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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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Wild-type KRAS Metastatic Colorectal Cancer

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Trial Information

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

Inclusion 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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC

Outcome Description:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Germany: Paul-Ehrlich-Institut (PEI)

Study ID:

20120100

NCT ID:

NCT01732783

Start Date:

December 2012

Completion Date:

September 2015

Related Keywords:

  • Wild-type KRAS Metastatic Colorectal Cancer
  • Wild-type KRAS
  • Metastatic Colorectal Cancer
  • Vectibix
  • Colorectal Neoplasms

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