Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR
NCT ID: NCT02322736
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
218 participants
OBSERVATIONAL
2014-11-21
2018-08-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe
NCT01791361
Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients
NCT01732783
European Physician Survey of EGFR Inhibitor Prescribing Patterns
NCT01652833
Lohp, 5-Fu/Lv and Bevacizumab, Alternative With Cpt-11, 5-Fu/Lv and Cetuximab In Metastatic Crc
NCT00755118
Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
NCT01024504
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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®.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
WT RAS mCRC
Wild Type RAS metastatic colorectal cancer patients
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Compromised ability to give informed consent (defined per clinical judgment).
* Unknown or mutant RAS tumor type
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ZeinCRO Hellas SA
INDUSTRY
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Ampelokipoi, Athens, , Greece
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Heraklion, , Greece
Research Site
Heraklion - Crete, , Greece
Research Site
Ioannina, , Greece
Research Site
Larissa, , Greece
Research Site
Maroussi, Athens, , Greece
Research Site
Nea Kifissia, Athens, , Greece
Research Site
Papagou, , Greece
Research Site
Piraeus, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Thessaloniki, , Greece
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20120286
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.