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

Part of paid clinical trials in Denver, Colorado.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT07011576
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fruquintinib — DRUG
    Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.
  • FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 29, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fruquinitinib + FOLFIRI
    Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled.

Primary Outcome Measure

Progression-Free Survival (PFS) rate at 6 months [ Time Frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days. ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer Center - PrimaryDenverColorado80218-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
Maryland Oncology HematologyColumbiaMaryland21044-
Minnesota Oncology Hematology - PrimaryMaple GroveMinnesota55369-
Missouri Cancer AssociatesColumbiaMissouri65201-
Oncology Associates of Oregon - PrimaryEugeneOregon97401-
Northwest Cancer Specialists - CompassPortlandOregon97213-
Alliance Cancer SpecialistsWynnewoodPennsylvania19096-
SCRI Oncology PartnersNashvilleTennessee37203-
Texas Oncology - Central/South TexasAustinTexas78705-
Texas Oncology - Gulf CoastBeaumontTexas77702-
Texas Oncology - Northeast TexasTylerTexas75702-
Virginia Oncology AssociatesNorfolkVirginia23502-
Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)SalemVirginia24153-

Find similar trials in Denver, CO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Rocky Mountain Cancer Center - Primary· Denver, COIllinois Cancer Specialists· Arlington Heights, ILMaryland Oncology Hematology· Columbia, MDMinnesota Oncology Hematology - Primary· Maple Grove, MNMissouri Cancer Associates· Columbia, MOOncology Associates of Oregon - Primary· Eugene, OR

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