SingleArmPhIV EvalSafe&EfficOral Fruquintinib Tx RefracMetsColoRecCa Pa UnderrepresentedMinorityPop
Study Description
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.
Eligibility
You must provide written (or electronic) informed consent.
You must be more than or equal to 18 years.
You have been previously treated with standard approved therapies: Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, An anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., bevacizumab, aflibercept, ramucirumab [regorafenib is NOT an anti-VEGF biologic]), and If RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy (e.g., cetuximab, panitumumab). If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor.
Self-identify as Black and/or African American or Hispanic and/or Latino or as both.
In participants of childbearing potential, agreement to use highly effective form(s) of contraception, which results in a low failure rate (less than [<]1 percent [%] per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire trial period, and for 2 weeks after taking the last dose of the trial intervention. Such methods include oral (PO) hormonal contraception (combined estrogen/progestogen or progestogen-only) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Those assigned male sex at birth must always use a condom.
Absolute neutrophil count (ANC) <1.5 times 10^9 per liter (10^9/L), platelet count <100 times 10^9/L, or hemoglobin <9.0 grams per deciliter (g/dL). Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed.
Serum total bilirubin more than (>)1.5 times the upper limit of normal range (ULN). Participants with previously documented Gilbert syndrome and bilirubin <2 times ULN are eligible.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times ULN in participants without hepatic metastases; ALT or AST >5 times ULN in participants with hepatic metastases.
Creatinine clearance <30 milliliters per minute (mL/min). Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation. Where available and appropriate, other formulae may be used to estimate clearance after consultation with the trial medical monitor.
Urine dipstick or urinalysis with protein ≥2 positive or 24-hour urine protein ≥1.0 gram per 24 hours (g/24 hours). Participants with 1+ positive proteinuria must undergo a 24-hour urine collection to assess urine protein level.
Uncontrolled hypertension, defined as systolic BP ≥140 millimeter of mercury (mmHg) and/or diastolic blood pressure (BP) ≥90 mmHg despite optimal medical management. The participant must have BP below both limits. Repeated assessments are permitted.
International normalized ratio (INR) >1.5 times ULN or activated partial thromboplastin time (aPTT) >1.5 times ULN, unless the participant is currently receiving or intended to receive anticoagulants for prophylactic purposes.a
