RECRUITING

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

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

Conditions

Colon CancerRectal CancerColorectal CancerColorectal Cancer (CRC)
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Related Conditions:

Colon CancerRectal CancerColorectal CancerColorectal Cancer (CRC)

Study Overview

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Study Details

Study overview

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

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

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

Condition
Colon Cancer
Intervention / Treatment

-

Contacts and Locations

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Tyler

Texas Oncology - Northeast Texas, Tyler, Texas, United States, 75702

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.

For general information about clinical research, read Learn About Studies.

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)
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
  • * 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 treatment received for mCRC prior to signing the ICFs
  • * Uncontrolled, symptomatic brain metastases
  • * Uncontrolled, symptomatic gastrointestinal disease
  • * Patients 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SCRI Development Innovations, LLC,

Meredith Pelster, MD, STUDY_CHAIR, SCRI Oncology Partners

Study Record Dates

2027-06