Fruquintinib in Patients With Metastatic Colorectal Cancer
ConditionMetastatic Colorectal Cancer (mCRC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients with mCRC receiving fruquintinib in Germany.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Real-world disease control rate (RW DCR)
The primary objective is to assess the effectiveness of fruquintinib in routine treatment. To this end, the real-world disease control rate will be analyzed, defined as the rate of complete response, partial response, or stable disease, either radiologically documented or clinically assessed by the treating physician.
Time frame
Start of treatment to end of treatment (avg. 6 months)Secondary outcomes
1
Best response
Further effectiveness objective: Best response radiologically documented or clinically assessed by the treating physician.
Time frame
Start of treatment to end of treatment (avg. 6 months)2
Overall response rate (ORR)
Further effectiveness objective: ORR is defined as proportion of patients with any response (partial or complete remission) overall, radiologically documented or clinically assessed by the treating physician.
Time frame
Start of treatment to end of treatment (avg. 6 months)3
Time to treatment failure (TTF)
Further effectiveness objective: TTF is defined as the time from treatment start to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death.
Time frame
Start of treatment to end of treatment (avg. 6 months)4
Time to next treatment (TTNT)
Further effectiveness objective: TTNT is defined as the interval from the start of fruquintinib treatment to initiation of the next line of therapy.
Time frame
Start of treatment to start of subsequent antineoplastic therapy (max. 33 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
iOMEDICO AG
Lead sponsor
Takeda GmbH
Collaborator
Source ClinicalTrials.gov