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
Fruquintinib is an FDA approved cancer medication that works by targeting proteins called vascular endothelial growth factor receptors (VEGFRs). VEGFRs are important in the creation of new blood vessels. As a highly-selective and potent VEGFR inhibitor, fruquintinib helps block new blood vessels that would provide nutrients and oxygen to cancerous tumors from forming. It is a small molecule anti-tumor drug with a novel chemical structure that belongs to the quinazoline class. This study is an open-label Phase II study designed to evaluate the efficacy and safety of fruquintinib + FOLFIRI in 2nd-line setting mCRC participants who have been previously treated with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab-based first-line therapy. Up to 60 participants will receive concurrent fruquintinib and FOLFIRI according to standard guidelines of treatment of mCRC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.
Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours.
Rocky Mountain Cancer Center - Primary
Denver, Colorado, United States
RECRUITINGMaryland Oncology Hematology
Columbia, Maryland, United States
RECRUITINGMinnesota Oncology Hematology - Primary
Maple Grove, Minnesota, United States
RECRUITINGOncology Associates of Oregon - Primary
Eugene, Oregon, United States
RECRUITINGNorthwest Cancer Specialists - Compass
Portland, Oregon, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGTexas Oncology - Central/South Texas
Austin, Texas, United States
RECRUITINGTexas Oncology - Gulf Coast
Beaumont, Texas, United States
RECRUITINGTexas Oncology - Northeast Texas
Tyler, Texas, United States
RECRUITINGVirginia Oncology Associates
Norfolk, Virginia, United States
RECRUITING...and 1 more locations
Progression-Free Survival (PFS) rate at 6 months
Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Overall Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of participants with confirmed CR or PR (i.e., 2 CRs or PRs at least 4 weeks apart) according to the RECIST Version 1.1.
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Duration of response (DoR)
Duration of Response (DoR), defined as the duration from the first documented response to the date of first documented PD or death due to any cause. In case a participant does not experience PD or death, DoR is censored at the date of last adequate tumor assessment (defined as an assessment of CR, PR, or SD). DoR analysis will include only responders (PR or better).
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Disease control response rate (DCR)
Disease Control Response Rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or SD.
Time frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Number of participants with treatment emergent adverse events
Using CTCAE V5.0
Time frame: Every 28 day cycle, from signed informed consent to 30 days after treatment discontinuation up to 1 year.
Overall Survival (OS)
Overall Survival (OS), defined as the time from the first day of study drug administration (Day 1) to death. Participants who are alive will be censored at the date of last known date alive. Each cycle is 28 days.
Time frame: From cycle 1 day 1 up to 2 years
Sarah Cannon Sarah Cannon Development Innovations, LLC
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.