RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07-28
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07011576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
  2. * Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
  3. * Participants must have received FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab- based first-line therapy for mCRC
  4. * At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
  1. * Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
  2. * Major surgery within 4 weeks of the first planned dose of study treatment
  3. * More than one treatment received for mCRC prior to signing the ICFs
  4. * Uncontrolled, symptomatic brain metastases
  5. * Uncontrolled, symptomatic gastrointestinal disease
  6. * Patients with uncontrolled hypertension
  7. * 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
  8. * Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
  9. * Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
  10. * Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
  11. * Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening

Contacts and Locations

Study Contact

Sarah Cannon Sarah Cannon Development Innovations, LLC
CONTACT
844-710-6157
SCRI.InnovationsMedical@scri.com

Principal Investigator

Meredith Pelster, MD
STUDY_CHAIR
SCRI Oncology Partners

Study Locations (Sites)

SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
United States

Collaborators and Investigators

Sponsor: SCRI Development Innovations, LLC

  • Meredith Pelster, MD, STUDY_CHAIR, SCRI Oncology Partners

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-28
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-07-28
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Colorectal cancer
  • Colon Cancer
  • Rectal cancer
  • Metastatic colorectal cancer
  • mCRC
  • VEGFR inhibitor
  • Fruquintinib
  • FOLFIRI
  • Second line
  • 2L mCRC

Additional Relevant MeSH Terms

  • Colon Cancer
  • Rectal Cancer
  • Colorectal Cancer
  • Colorectal Cancer (CRC)