Fruquintinib in Patients With Metastatic Colorectal Cancer

NCT ID: NCT06787105

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2027-12-31

Brief Summary

FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies.

To this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib.

Participants will be treated as decided by the treating physician and according to their routine practice.

Detailed Description

FRUQUENT is a prospective, multicenter, observational study in Germany, collecting real-world data of patients with metastatic colorectal cancer (mCRC) who receive fruquintinib according to the SmPC. The goal of the study is to analyze the effectiveness of the monotherapy with fruquintinib in adult patients with mCRC that have previously been treated with available standard therapies, including fluoropyrimidine, oxaliplatin-, and irintecan-based chemotherapies, anti-VEGF agents, and, if RAS wild-type, anti-EGFR agents. Moreover, the patients must have progressed on or be intolerant to treatment with either trifluridine/tipiracil or regorafenib.

All data for FRUQUENT will be obtained in routine clinical practice, allowing for a representative evaluation of the effectiveness of fruquintinib in a real-world setting. The study aims to recruit 150 patients in 50 practices (office based, oncology outpatient-centers or hospitals) to facilitate robust data.

Conditions

Metastatic Colorectal Cancer (mCRC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older.
• Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.
• Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.
• Progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib.
• Other criteria according to current SmPC.
• Signed written informed consent.* * Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.

Exclusion Criteria

• Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.
• Contraindications according to current SmPC.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda GmbH

INDUSTRY

Sponsor Role: collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Dr. med. Sebastian Stintzing

Role: PRINCIPAL_INVESTIGATOR

Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie

Locations

Onkologische Schwerpunktpraxis

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Max D Mai, MSc

Role: CONTACT

fruquent@iomedico.com

+49 761 152420

Facility Contacts

Dr. med. von der Heyde

Role: primary

info@onkologie-am-raschplatz.de

+49 511311660

Other Identifiers

iOM-100523

Identifier Type: -

Identifier Source: org_study_id