A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how often fruquintinib causes high blood pressure and how safe it is. It is for Black/African American and/or Hispanic/Latino adults with colon or rectal cancer that has spread and has already been treated.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and give written or electronic consent.
- Identify as Black/African American, Hispanic/Latino, or both.
- Have confirmed colon or rectal cancer that has spread. Your cancer’s RAS gene test result must be recorded.
- Have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan, plus a medicine that blocks blood vessel growth.
- Have received other required treatments based on your cancer’s gene test results, if medically appropriate.
- Weigh at least 40 kilograms (about 88 pounds) and be able to do daily activities with little or no limits.
- Have cancer that the study team can assess using standard tests.
- If you can become pregnant, use highly effective birth control during screening, the study, and for 2 weeks after the last dose. People assigned male at birth must always use a condom.
Who can't join
- Certain low blood counts, abnormal liver or kidney tests, too much protein in urine, or abnormal blood-clotting tests.
- Blood pressure of 140 or higher on top, or 90 or higher on bottom, despite treatment.
- Certain gut ulcers, bleeding, holes, or abnormal connections; other recent bleeding; blood clots within 6 months; or stroke or mini-stroke within 12 months.
- Serious heart disease, certain abnormal heart rhythms, or a high risk of heart rhythm problems.
- Cancer treatment, radiation, surgery, or an invasive procedure too close to starting the study; an unhealed wound; or certain lasting side effects from earlier treatment.
- Known HIV, certain active hepatitis infections, or an uncontrolled infection needing antibiotics through a vein.
- Cancer growing into a large blood vessel; untreated or not stable cancer in the brain or pressure on the spinal cord; certain recent steroid use; or certain other cancers.
- Pregnancy or breastfeeding, trouble swallowing or absorbing medicine, or another health condition the study doctor believes could prevent participation.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Provide written (or electronic) informed consent. 2. Male or female aged more than or equal to (≥)18 years. 3. Presence of histologically and/or cytologically documented metastatic colorectal adenocarcinoma. Rat sarcoma virus (RAS) status for each participant must be documented. 4. 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. 5. Self-identify as Black and/or African American or Hispanic and/or Latino or as both. 6. Body weight ≥40 kilograms (kg). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening. 8. Have assessable disease according to RECIST version 1.1, assessed locally. 9. 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. History of or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas, or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation within the 6 months prior to screening. 9. History or presence of hemorrhage from any other site (e.g, hemoptysis or hematemesis) within 2 months prior to screening. 10. History of a thromboembolic event, including deep vein thrombosis, pulmonary embolism, or arterial embolism within 6 months prior to screening. 11. Stroke and/or transient ischemic attack within 12 months prior to screening. 12. Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction \<50% by echocardiogram. 13. QT interval, corrected using the Fridericia method (QTcF) \>480 milliseconds or any factors that increase the risk of QT interval, corrected based on the patient's heart rate (QTc) prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, or family history of long QT syndrome. 14. Systemic antineoplastic therapies (except for that described in exclusion criterion no. 15) or any investigational therapy within 2 weeks prior to the first dose of the trial intervention, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy. 15. Systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors \[TKIs\]) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of the trial intervention. 16. Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of the trial intervention. 17. Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of the trial intervention. 18. Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 14 days prior to the first dose of the trial intervention or unhealed surgical incision. 19. Any unresolved toxicities from previous antitumor treatments greater than NCI CTCAE, version 5.0, Grade 1 (except for alopecia or neurotoxicity Grade less than or equal to \[≤\]2). 20. Known human immunodeficiency virus infection. 21. Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load had to be undetectable on suppressive therapy, if indicated. Participants with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load. 22. Clinically uncontrolled active infection requiring intravenous (IV) antibiotics. 23. Tumor invasion of a large vascular structure (e.g., pulmonary artery or superior or inferior vena cava). 24. Those who are currently pregnant or lactating. 25. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of SD for 14 days or longer; participants requiring steroids within 4 weeks prior to the start of the trial intervention are to be excluded. 26. Other malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or bladder carcinoma (tumor in situ and T1) that had been adequately treated during the 5 years prior to screening. Participants with another primary malignancy that has been adequately treated may be included after consultation with the trial medical monitor. 27. Inability to take medication PO, dysphagia, or an active gastric ulcer resulting from previous surgery (e.g., gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe might affect absorption of the investigational medicinal product (IMP). 28. Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect might prohibit use of the IMP, affect interpretation of trial results, or put the participant at undue risk of harm based on the investigator's assessment. 29. Known hypersensitivity to fruquintinib or any of its inactive ingredients, including the azo dyes Tartrazine- Federal Food, Drug, and Cosmetic Act (FD\&C) Yellow 5 and Sunset yellow For Coloring Food (FCF)-FD\&C Yellow 6. 30. Received prior fruquintinib. 31. Live vaccine ≤28 days before the first dose of the trial intervention. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed. 32. Use of strong inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose of the trial intervention.
Study sites (44)
AL
- Central Alabama Research · Birmingham, AL 35209Site Contact · Study contact · 205-949-1907 · kashraf@centralalabamaresearch.comKhaleel Ashraf · Principal investigatorMore trials in Birmingham
- University of Alabama at Birmingham · Birmingham, AL 35249Site Contact · Study contact · 205-996-2106 · ggupta@uabmc.eduGarima Gupta · Principal investigatorMore trials in Birmingham
AZ
- Ironwood Cancer and Research Centers · Chandler, AZ 85224Site Contact · Study contact · 480-969-3637 · dharia@ironwoodcrc.comNeel Dharia · Principal investigatorMore trials in Chandler
- University of Arizona · Tucson, AZ 85719Site Contact · Study contact · 520-626-3199 · ajscott@arizona.eduAaron Scott · Principal investigatorMore trials in Tucson
CA
- University of California San Diego · La Jolla, CA 92093Site Contact · Study contact · 858-822-3115 · gbotta@ucsd.eduGregory Botta · Principal investigatorMore trials in La Jolla
- University of Southern California · Los Angeles, CA 90033Site Contact · Study contact · 323-865-3000 · algaze@usc.eduSandra Algaze · Principal investigatorMore trials in Los Angeles
- PIH Health Whittier Hospital · Whittier, CA 90602Site Contact · Study contact · 156-269-8081 · Andrew.Pham@pihhealth.orgAndrew Pham · Principal investigatorMore trials in Whittier
DE
- Christiana Care Health Services · Newark, DE 19713Site Contact · Study contact · 302-366-1200 · jmisleh@cbg.orgJamal Misleh · Principal investigatorMore trials in Newark
FL
- University of Florida · Gainesville, FL 32610More trials in Gainesville
- University of Miami · Miami, FL 33146More trials in Miami
- Baptist Health - Miami Cancer Institute · Miami, FL 33176More trials in Miami
GA
- Emory University · Atlanta, GA 30322Site Contact · Study contact · 404-778-1900 · olatunji.alese@emory.eduOlatunji Alese · Principal investigatorMore trials in Atlanta
IL
- Hope and Healing Cancer Services · Hinsdale, IL 60521Site Contact · Study contact · 630-560-0121 · sgundala@hopenheal.careSrilata Gundala · Principal investigatorMore trials in Hinsdale
IN
- Indiana University · Indianapolis, IN 46202Site Contact · Study contact · 317-944-0920 · aalhader@iu.eduAnita Turk · Principal investigatorMore trials in Indianapolis
LA
- Our Lady of the Lake Physician Group - LSU Health Baton Rouge Oncology · Baton Rouge, LA 70805Site Contact · Study contact · 225-358-2312 · stagg.patrick@yahoo.comMarshall Stagg · Principal investigatorMore trials in Baton Rouge
- Willis Knighton Cancer Center · Shreveport, LA 71103Site Contact · Study contact · 318-212-8620 · jfeagin@wkhs.comJoyce Feagin · Principal investigatorMore trials in Shreveport
MA
- Boston Medical Center · Boston, MA 02118More trials in Boston
MD
- Mercy Medical Center · Baltimore, MD 21202Site Contact · Study contact · 410-783-5858 · pledakis@mdmercy.comPanayotis Ledakis · Principal investigatorMore trials in Baltimore
MO
- Saint Luke's Cancer Institute · Kansas City, MO 64111More trials in Kansas City
- Midwest Oncology Associates - Kansas City · Kansas City, MO 64132Site Contact · Study contact · 816-974-5050 · jaswinder.singh@amrllc.comJaswinder Singh · Principal investigatorMore trials in Kansas City
- SSM Health St. Louis DePaul Hospital · St Louis, MO 63044Site Contact · Study contact · 314-209-5142 · brian.smith@ssmhealth.comBrian Smith · Principal investigatorMore trials in St Louis
- Washington University School of Medicine · St Louis, MO 63108Site Contact · Study contact · 314-273-3564 · nikolaos@wustl.eduNikolaos Andreatos · Principal investigatorMore trials in St Louis
MS
- Hattiesburg Clinic · Hattiesburg, MS 39401Site Contact · Study contact · 601-261-1700 · bo.hrom@hattiesburgclinic.comJohn Hrom · Principal investigatorMore trials in Hattiesburg
NJ
- Capital Health Medical Center - Hopewell · Pennington, NJ 08534Site Contact · Study contact · 609-303-0747 · ALoaiza-Bonilla@capitalhealth.orgHongyan Liang · Principal investigatorMore trials in Pennington
NY
- Columbia University · New York, NY 10032More trials in New York
- Albert Einstein College of Medicine · The Bronx, NY 10461More trials in The Bronx
- James J Peters Veterans Administration Medical Center - NAVREF · The Bronx, NY 10468More trials in The Bronx
OH
- Zangmeister Cancer Center · Columbus, OH 43219Site Contact · Study contact · 614-383-6194 · smikhail@zangcenter.comSameh Mikhail · Principal investigatorMore trials in Columbus
OK
- Hightower Clinical Research · Oklahoma City, OK 73102More trials in Oklahoma City
PA
- Jefferson Health · Philadelphia, PA 19107Site Contact · Study contact · 267-402-0579 · Atrayee.BasuMallick@jefferson.eduAtrayee Basu-Mallick · Principal investigatorMore trials in Philadelphia
- Fox Chase Cancer Center | Philadelphia, PA · Philadelphia, PA 19111More trials in Philadelphia
SC
- Medical University of South Carolina · Charleston, SC 29425More trials in Charleston
TN
- University of Tennessee -- Memphis · Memphis, TN 38163Site Contact · Study contact · 475-434-0816 · schokshi@uthsc.eduSaurin Chokshi · Principal investigatorMore trials in Memphis
- Vanderbilt University Medical Center · Nashville, TN 37212Site Contact · Study contact · 317-944-0920 · brooke.d.looney@vumc.orgBrooke Looney · Principal investigatorMore trials in Nashville
TX
- University of Texas Southwestern Medical Center · Dallas, TX 75390Site Contact · Study contact · 214-648-4180 · Nilesh.Verma@UTSouthwestern.eduNilesh Verma · Principal investigatorMore trials in Dallas
- Renovatio Clinical · El Paso, TX 79915Site Contact · Study contact · 713-703-2398 · mary.crow@renovatioclinical.comMary Crow · Principal investigatorMore trials in El Paso
- Oncology Consultants - Memorial City Location · Houston, TX 77030Site Contact · Study contact · 713-600-0071 · jpeguero@OncologyConsultants.comJulio Peguero · Principal investigatorMore trials in Houston
- Baylor College of Medicine · Houston, TX 77054Site Contact · Study contact · 713-798-4951 · karen.riggins@bcm.eduKaren Riggins · Principal investigatorMore trials in Houston
- BRCR Global · Katy, TX 77450More trials in Katy
- Renovatio Clinical · The Woodlands, TX 77380Site Contact · Study contact · 713-703-2398 · jonathan.lu@renovatioclinical.comJonathon Lu · Principal investigatorMore trials in The Woodlands
- Tranquil Research · Webster, TX 77598Site Contact · Study contact · 713-907-6054 · drknecht@cls.healthJohn Knecht · Principal investigatorMore trials in Webster
VA
- UC Irvine Medical Center - Chao Family Comprehensive Cancer · Orange, VA 22960Site Contact · Study contact · 714-456-2242 · fdayyani@uci.eduFarshid Dayyani · Principal investigatorMore trials in Orange
- Virginia Commonwealth University · Richmond, VA 23298Site Contact · Study contact · 804-628-2945 · khalid.matin@vcuhealth.orgKhalid Matin · Principal investigatorMore trials in Richmond
WA
- Medstar Speciality Hospital · Northwest, WA 20010Site Contact · Study contact · 202-877-4072 · marcus.s.noel@gunet.georgetown.eduMarcus Noel · Principal investigatorMore trials in Northwest