Evaluating Fruquintinib for Metastatic Colorectal Cancer
Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study
This study is testing how well Fruquintinib works for people with metastatic colorectal cancer who have already tried other treatments, to see how it affects their survival and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Drugs / interventions | fruquintinib |
| Locations | 1 site (Hanover, Lower Saxony) |
| Trial ID | NCT06787105 on ClinicalTrials.gov |
What this trial studies
This observational study, known as FRUQUENT, is being conducted in Germany to assess the effectiveness of Fruquintinib in patients with metastatic colorectal cancer (mCRC) who have previously undergone standard therapies. The study will collect real-world data on patient responses to Fruquintinib, including survival rates, safety, healthcare utilization, and quality of life. It aims to enroll 150 patients across 50 clinical practices, allowing for a comprehensive evaluation of treatment outcomes in routine clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with metastatic colorectal cancer who have progressed on or are intolerant to standard therapies.
Not a fit: Patients currently participating in interventional clinical trials or those with contraindications to Fruquintinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Fruquintinib as a treatment option for patients with mCRC who have limited alternatives.
How similar studies have performed: While this study utilizes a real-world data approach, similar studies assessing the effectiveness of treatments for mCRC have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hanover, Lower Saxony
- Onkologische Schwerpunktpraxis — Hanover, Lower Saxony, Germany (Recruiting)
Study contacts
- Principal investigator: Professor Dr. med. Sebastian Stintzing — Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie
- Study coordinator: Max D Mai, MSc
- Email: fruquent@iomedico.com
- Phone: +49 761 152420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.