A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland

Takeda

Status: Not yet enrolling

Conditions: Metastatic Colorectal Cancer

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT07623174

TAK-113-4011

Details and patient eligibility

About

Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.

The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.

Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.

The study will look at data already existing in the participants' medical charts.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride/tipiracil.
2. Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.
3. Participants for whom adequate medical records are available to support the data collection requirements.

Exclusion criteria

1. Participant currently participates or plans to participate in an interventional clinical trial.

Trial design

110 participants in 1 patient group

Participants with mCRC

Description:

Adult participants with metastatic colorectal cancer (mCRC) who initiate treatment with fruquintinib under reimbursement program will be included. Participants will be observed for 12 months after treatment initiation, or until death.

Treatment:

Other: No intervention