A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
Purpose
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.
Condition
- Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Fruquintinib 5 mg |
Participants will receive fruquintinib capsule at a dose of 5 mg, orally (PO), once daily (QD), for the first 21 days of each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or other discontinuation criteria are met. |
|
Recruiting Locations
Central Alabama Research
Birmingham, Alabama 35209
Birmingham, Alabama 35209
University of Alabama at Birmingham
Birmingham, Alabama 35249
Birmingham, Alabama 35249
Ironwood Cancer and Research Centers
Chandler, Arizona 85224
Chandler, Arizona 85224
University of California San Diego
La Jolla, California 92093
La Jolla, California 92093
University of Southern California
Los Angeles, California 90033
Los Angeles, California 90033
PIH Health Whittier Hospital
Whittier, California 90602
Whittier, California 90602
Christiana Care Health Services
Newark, Delaware 19713
Newark, Delaware 19713
Hope and Healing Cancer Services
Hinsdale, Illinois 60521
Hinsdale, Illinois 60521
Our Lady of the Lake Physician Group - LSU Health Baton Rouge Oncology
Baton Rouge, Louisiana 70805
Baton Rouge, Louisiana 70805
Willis Knighton Cancer Center
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
Mercy Medical Center
Baltimore, Maryland 21202
Baltimore, Maryland 21202
Hattiesburg Clinic
Hattiesburg, Mississippi 39401
Hattiesburg, Mississippi 39401
Midwest Oncology Associates - Kansas City
Kansas City, Missouri 64132
Kansas City, Missouri 64132
SSM Health St. Louis DePaul Hospital
St Louis, Missouri 63044
St Louis, Missouri 63044
Washington University School of Medicine
St Louis, Missouri 63108
St Louis, Missouri 63108
Capital Health Medical Center - Hopewell
Pennington, New Jersey 08534
Pennington, New Jersey 08534
Zangmeister Cancer Center
Columbus, Ohio 43219
Columbus, Ohio 43219
Jefferson Health
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
University of Tennessee -- Memphis
Memphis, Tennessee 38163
Memphis, Tennessee 38163
Vanderbilt University Medical Center
Nashville, Tennessee 37212
Nashville, Tennessee 37212
University of Texas Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
Renovatio Clinical
El Paso, Texas 79915
El Paso, Texas 79915
Oncology Consultants - Memorial City Location
Houston, Texas 77030
Houston, Texas 77030
Baylor College of Medicine
Houston, Texas 77054
Houston, Texas 77054
Renovatio Clinical
The Woodlands, Texas 77380
The Woodlands, Texas 77380
UC Irvine Medical Center - Chao Family Comprehensive Cancer
Orange, Virginia 22960
Orange, Virginia 22960
Virginia Commonwealth University
Richmond, Virginia 23298
Richmond, Virginia 23298
Medstar Speciality Hospital
Northwest, Washington 20010
Northwest, Washington 20010
More Details
- Status
- Recruiting
- Sponsor
- Takeda