OncoMatch/Clinical Trials/NCT06562543
A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
Is NCT06562543 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Fruquintinib for colorectal cancer.
Treatment: Fruquintinib — High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS status documented
Rat sarcoma virus (RAS) status for each participant must be documented.
Required: NRAS status documented
Rat sarcoma virus (RAS) status for each participant must be documented.
Allowed: EGFR wild-type
If RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy (e.g., cetuximab, panitumumab)
Allowed: MSH2 deficient mismatch repair
If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor
Allowed: MSH6 deficient mismatch repair
If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor
Allowed: MLH1 deficient mismatch repair
If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor
Allowed: PMS2 deficient mismatch repair
If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine-based chemotherapy
Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Must have received: oxaliplatin-based chemotherapy
Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Must have received: irinotecan-based chemotherapy
Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Must have received: anti-VEGF biological therapy (bevacizumab, aflibercept, ramucirumab)
An anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., bevacizumab, aflibercept, ramucirumab [regorafenib is NOT an anti-VEGF biologic])
Must have received: anti-EGFR therapy (cetuximab, panitumumab)
If RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy (e.g., cetuximab, panitumumab)
Must have received: anti-PD-1 therapy
If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor
Cannot have received: fruquintinib (fruquintinib)
Received prior fruquintinib
Lab requirements
Blood counts
ANC ≥1.5x10^9/L, platelets ≥100x10^9/L, hemoglobin ≥9.0 g/dL
Kidney function
Creatinine clearance ≥30 mL/min
Liver function
Serum total bilirubin ≤1.5x ULN (Gilbert syndrome <2x ULN eligible); ALT/AST ≤2.5x ULN (≤5x ULN with hepatic metastases)
Cardiac function
QTcF ≤480 ms; LVEF ≥50% by echocardiogram; no NYHA Class III/IV CHF, no recent MI or CABG within 6 months, no severe/unstable angina, no ventricular arrhythmias requiring treatment
ANC <1.5x10^9/L, platelets <100x10^9/L, hemoglobin <9.0 g/dL [excluded]. Serum total bilirubin >1.5x ULN [excluded]. ALT or AST >2.5x ULN (no hepatic mets) or >5x ULN (with hepatic mets) [excluded]. Creatinine clearance <30 mL/min [excluded]. QTcF >480 ms [excluded]. LVEF <50% by echocardiogram [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Central Alabama Research · Birmingham, Alabama
- University of Alabama at Birmingham · Birmingham, Alabama
- Ironwood Cancer and Research Centers · Chandler, Arizona
- University of Arizona · Tucson, Arizona
- University of California San Diego · La Jolla, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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