Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR

Metastatic Colorectal Cancer Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322736
• Other study ID #: 20120286
• Status: Completed
• Start date: November 21, 2014
• Est. completion date: August 3, 2018

Study information

• Verified date: November 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a single-arm, multi-center, prospective, observational, descriptive, noninterventional study in patients with mCRC in Greece who receive Vectibix®in 1st or 2nd line according to approved indication. The aim of the study is to obtain a clear understanding of the current practices concerning real-life treatment of mCRC patients with Vectibix® in first-line in combination with chemotherapy or second-line in combination with chemotherapy in Greece. This setting will also provide the opportunity to observe in a non-selected patient population with RAS WT mCRC the real-life habits of mCRC treatment, and in particular the duration and the outcomes of Vectibix® treatment. The data generated by this study may be used for reimbursement purposes, as it becomes an increasingly common need in Greece to provide locally generated data for use of drugs in the real-life setting to regulatory agencies and/or payors. Furthermore, this study could address the existing data gap in the treatment of anti-EGFR therapy beyond progression in the real-life setting.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Greece	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

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	ZeinCRO Hellas SA

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Frequency of primary tumor resection in the entire number of the study participants (patients with WT RAS mCRC included in the study).; Frequency of metastatic lesion resection in entire number of the study participants.; Frequency of BRAF testing in the entire number of the study participants. Frequency of BRAF mutation in the unselected Greek patient population with WT RAS mCRC included in the study.	42 months
Primary	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	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®.	Objective response rate (ORR) of the 1st line chemotherapy treatment including Vectibix®.; Objective response rate (ORR) of the 2nd line chemotherapy treatment including Vectibix®.; Stable disease rate (SD) of the 1st line chemotherapy treatment including Vectibix®.; Stable disease rate (SD) of the 2nd line chemotherapy treatment including Vectibix®.	42 months

External Links

•   AmgenTrials clinical trials website