Clinical trial NCT02322736: Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer, wild type RAS, Panitumumab, Vectibix, Greece
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: ZeinCRO Hellas SA
First posted: 2014-12-23
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed 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®.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 42 months
Secondary outcomes:
measure: 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®.
timeFrame: 42 months
Other outcomes:
measure: 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.
timeFrame: 42 months
Locations:
city: Ampelokipoi, Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion - Crete
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Maroussi, Athens
country: Greece
facility: Research Site
city: Nea Kifissia, Athens
country: Greece
facility: Research Site
city: Papagou
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: