A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to: * Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting * Evaluate the safety of the combination of fruquintinib + FOLFIRI

Trial Details

NCT ID
NCT07011576
Phase
PHASE2
Sponsor
SCRI Development Innovations, LLC
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • fruquintinib
  • FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Locations (sample)
  • Denver, Colorado, United States|39.73915,-104.9847
  • Arlington Heights, Illinois, United States|42.08836,-87.98063
  • Columbia, Maryland, United States|39.24038,-76.83942
  • Maple Grove, Minnesota, United States|45.07246,-93.45579
  • Columbia, Missouri, United States|38.95171,-92.33407

Key Eligibility 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 FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab- based first-line therapy for mCRC
  • At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)

For full eligibility, visit ClinicalTrials.gov.

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