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New treatment option for Metastatic Colorectal Adenocarcinoma
Official title Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07130903
What this study is testing
What is Fruquintinib?
Fruquintinib is an investigational medicine, being studied as a potential treatment for metastatic colorectal adenocarcinoma.
Also referred to as Fruzaqla, HMPL-013.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to Fruquintinib in metastatic colorectal cancer that has not responded to other standard treatment is: Effective in improving survival safe and tolerable
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Participant must have histologically or cytologically confirmed metastatic colorectal adenocarcinoma. There must be previous documentation of RAS...
- Participant must have progressed on or been intolerant to the following previous treatments (if not contraindicated):
- Fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy
- Anti-VEGF (vascular endothelial growth factor) biological therapy, such as bevacizumab, aflibercept, or ramucirumab
- If RAS is wild type, an anti-EGFR (epidermal growth factor receptor) therapy like cetuximab or panitumumab
You likely can't join if
- Participants with uncontrolled hypertension per investigator discretion.
- Participants with a history or presence of gastric/duodenal ulcer or ulcerative colitis, hemorrhage of an unresected gastrointestinal tumor...
- Participants with a history or presence of hemorrhage from any other site (i.e., lower GI bleed, hemoptysis or hematemesis) within two months prior...
- Participants with a history of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within...
- Participants with a history of stroke and/or transient ischemic attack within 12 months prior to screening.
- Participants with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass...
See the full eligibility criteria
Who can join
- Participant must have histologically or cytologically confirmed metastatic colorectal adenocarcinoma. There must be previous documentation of RAS (Rat sarcoma mutation), BRAF (B-Raf proto-oncogene, Serine/threonine...
- Participant must have progressed on or been intolerant to the following previous treatments (if not contraindicated):
- Fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy
- Anti-VEGF (vascular endothelial growth factor) biological therapy, such as bevacizumab, aflibercept, or ramucirumab
- If RAS is wild type, an anti-EGFR (epidermal growth factor receptor) therapy like cetuximab or panitumumab
- Participant must have evaluable disease as defined by the investigator using CT (computed tomography), MRI (magnetic resonance imaging), or PET (positron emission tomograph) scan.
- Participant must have a body weight ≥ 40 kg.
- Participant must be aged 22 years or older.
- Participant must be able to understand a written informed consent document and be willing to sign it.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Participant must have adequate organ and marrow function within 14 days prior to the initiation of treatment as described below:
- Participant should have an expected lifespan of \>12 weeks as determined by the investigator.
- Fruquintinib is suspected to cause loss of human pregnancy and impaired development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant and male participants should...
What rules you out
- Participants with uncontrolled hypertension per investigator discretion.
- Participants with a history or presence of gastric/duodenal ulcer or ulcerative colitis, hemorrhage of an unresected gastrointestinal tumor, perforation, fistulas, or any other condition that could, in the...
- Participants with a history or presence of hemorrhage from any other site (i.e., lower GI bleed, hemoptysis or hematemesis) within two months prior to screening.
- Participants with a history of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within three months prior to screening unless they are on a stable dose of...
- Participants with a history of stroke and/or transient ischemic attack within 12 months prior to screening.
- Participants with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within six months prior to enrollment, severe or unstable...
- Participants with corrected QT interval using the Fridericia method (QTcF) \> 480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT...
- Participants taking concomitant medications with a known risk of causing QT prolongation and/or torsades de pointes. (Source list is continuously updated online at www.crediblemeds.org.)
- Participants taking systemic anti-neoplastic therapies four weeks prior to the first dose of study drug, including chemotherapy, biotherapy, or immunotherapy. Palliative radiation is allowed if it does not cover all...
- Participants taking systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors) within five half-lives or four weeks, whichever is shorter, prior to the first dose of study drug.
- Participants who have undergone major surgery within 30 days prior to the first dose of study drug or if they still have unhealed surgical incision from previous surgery.
- Participants with any unresolved toxicities from a previous antitumor treatment greater than NCI CTCAE v5.0 grade 2.
- Participants that have current drug or alcohol abuse.
- Participants with known human immunodeficiency virus (HIV) infection are not eligible if their viral load and/or CD4 (cluster of differentiation 4) count are considered poorly controlled with anti-HIV therapy.
- Participants with a known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated...
- Participants with clinically uncontrolled active infections requiring intravenous antibiotics.
- Participants with tumor invasion of a large vascular structure (e.g., pulmonary artery, superior or inferior vena cava).
- Participants with brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy and without clinical imaging evidence of stable disease for 14 days or longer.
- Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and how well it works of the endpoints.
- Participants that are unable to take medication orally including those with dysphagia or an active gastric ulcer resulting from previous surgery (e.g., gastric bypass) or severe gastrointestinal disease, or any other...
- Participants with metabolic disorder that the investigator suspects may prohibit fruquintinib action, affect interpretation of study results, or put the participant at undue risk of harm based on the investigator's...
- Participants that have received prior fruquintinib treatment.
- Participants with a known hypersensitivity to fruquintinib or any of its inactive ingredients including the azo dyes tartrazine, FD\&C yellow 5, and sunset yellow FCF.
- Participants taking strong inducers or inhibitors of CYP3A4 within five half-lives or four weeks, whichever is longer, before the first dose of study drug. Refer to Appendix 2 for a comprehensive list of excluded...
- Participants that are taking any other investigational drugs.
- Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes...
- Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid/vitamin C, etc.) unless these...
- Participants that are pregnant or breastfeeding are ineligible for this study. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued.
- Participants who have received a live vaccine ≤ 28 days before the first dose of fruquintinib. (Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines...
- Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.
The study team makes the final eligibility decision.
Where it's taking place
- Bay City, Michigan, United States
- Clarkston, Michigan, United States
- Detroit, Michigan, United States
- Flint, Michigan, United States
- Lansing, Michigan, United States
- Lapeer, Michigan, United States
- Macomb, Michigan, United States
- Petoskey, Michigan, United States
- Port Huron, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bay City, Michigan, United States; Clarkston, Michigan, United States; Detroit, Michigan, United States; Flint, Michigan, United States; Lansing, Michigan, United States; Lapeer, Michigan, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.