Clinical trial NCT07011576: A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Official title: A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Colon Cancer
Rectal Cancer
Colorectal Cancer
Colorectal Cancer (CRC)
Keywords: Colorectal cancer
Colon Cancer
Rectal cancer
Metastatic colorectal cancer
mCRC
VEGFR inhibitor
Fruquintinib
FOLFIRI
Second line
2L mCRC
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2025-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Key Inclusion 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

Key Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-Free Survival (PFS) rate at 6 months
timeFrame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
measure: Duration of response (DoR)
timeFrame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
measure: Disease control response rate (DCR)
timeFrame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
measure: Number of participants with treatment emergent adverse events
timeFrame: Every 28 day cycle, from signed informed consent to 30 days after treatment discontinuation up to 1 year.
measure: Overall Survival (OS)
timeFrame: From cycle 1 day 1 up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Oncology Partners
name: Meredith Pelster, MD
role: STUDY_CHAIR
References: