NCT06787105 Fruquintinib in Patients With Metastatic Colorectal Cancer
| NCT ID | NCT06787105 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iOMEDICO AG |
| Condition | Metastatic Colorectal Cancer (mCRC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-02-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. FRUQUENT is accompanied by a translational research project combining real-world clinical data with foundational research to stratify patient collectives in regards to the therapeutic benefit of fruquintinib.
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.
Contact & Investigator
Professor Dr. med. Sebastian Stintzing
PRINCIPAL INVESTIGATOR
Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie
Frequently Asked Questions
Who can join the NCT06787105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Cancer (mCRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06787105 currently recruiting?
Yes, NCT06787105 is actively recruiting participants. Contact the research team at fruquent@iomedico.com for enrollment information.
Where is the NCT06787105 trial being conducted?
This trial is being conducted at Hanover, Germany.
Who is sponsoring the NCT06787105 clinical trial?
NCT06787105 is sponsored by iOMEDICO AG. The principal investigator is Professor Dr. med. Sebastian Stintzing at Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie. The trial plans to enroll 150 participants.
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