Fruquintinib plus FOLFIRI for second-line metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter, single-arm Phase II trial enrolling up to 60 participants to receive fruquintinib together with standard FOLFIRI chemotherapy. Participants must have histologically confirmed metastatic colorectal adenocarcinoma with at least one measurable lesion and prior first-line treatment with FOLFOX plus bevacizumab. The study will give concurrent fruquintinib and FOLFIRI according to standard dosing schedules and monitor tumor response by RECIST and safety outcomes. Primary goals are to see if the combination provides clinical benefit in the second-line setting and to characterize its tolerability.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
* Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
* Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
* At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2

Key Exclusion Criteria:

* Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
* Major surgery within 4 weeks of the first planned dose of study treatment
* More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
* Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
* Uncontrolled, symptomatic brain metastases
* Uncontrolled, symptomatic gastrointestinal disease
* Participants with uncontrolled hypertension
* Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
* Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
* Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
* Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening

Where it's running

• Rocky Mountain Cancer Center - Primary
  Denver, Colorado, United States Recruiting
• Illinois Cancer Specialists
  Arlington Heights, Illinois, United States Recruiting
• Maryland Oncology Hematology
  Columbia, Maryland, United States Recruiting
• Minnesota Oncology Hematology - Primary
  Maple Grove, Minnesota, United States Recruiting
• Missouri Cancer Associates
  Columbia, Missouri, United States Recruiting
• Oncology Associates of Oregon - Primary
  Eugene, Oregon, United States Recruiting

Study contacts

• Study coordinator: Sarah Cannon Sarah Cannon Development Innovations, LLC
• Email: SCRI.InnovationsMedical@scri.com
• Phone: 844-710-6157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.