Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR
VISION
A Prospective Observational Study of 1st and 2nd Line Vectibix® Use in KRAS/NRAS-wt mCRC Patients to Evaluate Pattern of Use and Overall Response Rates
1 other identifier
observational
218
1 country
20
Brief Summary
The study will shed additional light on the impact of Vectibix® under the current, standard clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the outcomes of Vectibix® treatment in real-life setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2014
CompletedFirst Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2018
CompletedNovember 13, 2019
November 1, 2019
3.7 years
December 19, 2014
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC will be decribed according to the following information: * Type of chemotherapy combined with Vectibix® * Starting dose and dose administration schedule of Vectibix® and chemotherapy * Cumulative dose, maximum dose, duration of exposure and total number of infusions received from the initiation of Vectibix® therapy and chemotherapy * Dose alterations for Vectibix and chemotherapy (including changes in frequency, reductions and/or delays).
42 months
Secondary Outcomes (1)
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®.
42 months
Other Outcomes (1)
Frequency of primary tumor resection, of metastatic lesion resection, of BRAF testing in the entire number of the study participants and frequency of BRAF mutation in the unselected Greek patient population with WT RAS mCRC included in the study.
42 months
Study Arms (1)
WT RAS mCRC
Wild Type RAS metastatic colorectal cancer patients
Eligibility Criteria
Target population will be adult patients (aged ≥ 18 years at enrollment) with a documented diagnosis of a RAS WT mCRC preferably measurable disease per modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) if routinely used, who are currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen including Vectibix® as per indication.
You may qualify if:
- Adult patient (age ≥18 years) at enrollment
- 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
You may not qualify if:
- Participation in any interventional clinical study (currently or during the three previous months from enrollment).
- Compromised ability to give informed consent (defined per clinical judgment).
- Unknown or mutant RAS tumor type
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- ZeinCRO Hellas SAcollaborator
Study Sites (20)
Research Site
Ampelokipoi, Athens, 11521, Greece
Research Site
Athens, 11522, Greece
Research Site
Athens, 11525, Greece
Research Site
Athens, 11527, Greece
Research Site
Athens, 11528, Greece
Research Site
Athens, 12462, Greece
Research Site
Athens, 14564, Greece
Research Site
Athens, 15562, Greece
Research Site
Heraklion, 71409, Greece
Research Site
Heraklion - Crete, 71110, Greece
Research Site
Ioannina, 45500, Greece
Research Site
Larissa, 41221, Greece
Research Site
Maroussi, Athens, 15123, Greece
Research Site
Nea Kifissia, Athens, 14564, Greece
Research Site
Papagou, 11526, Greece
Research Site
Piraeus, 18537, Greece
Research Site
Thessaloniki, 54007, Greece
Research Site
Thessaloniki, 54622, Greece
Research Site
Thessaloniki, 55236, Greece
Research Site
Thessaloniki, 56429, Greece
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2014
First Posted
December 23, 2014
Study Start
November 21, 2014
Primary Completion
August 3, 2018
Study Completion
August 3, 2018
Last Updated
November 13, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request