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Cabozantinib for Pancreatic Neuroendocrine Tumors
Study Summary
This trial compares cabozantinib to placebo in treating neuroendocrine or carcinoid tumors. Cabozantinib is a chemotherapy drug that targets specific tyrosine kinase receptors, which when blocked, may slow tumor growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT02315430Trial Design
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- My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.You do not have any hollow spaces in your lungs.I do not have a history of inherited long QT syndrome.I have not had a GI perforation in the last 6 months.My cancer has not spread to or around any major blood vessels.I am 18 years old or older.My condition worsened or I couldn't tolerate my previous FDA-approved treatment.I haven't had serious stomach bleeding in the last 6 months.My tumor has not invaded my digestive system, risking perforation or bleeding recently.I can swallow pills without any issues.I have taken a pregnancy test within the last 14 days and it was negative.Your platelet count should be at least 100,000 per cubic millimeter.Your calcium levels are within the normal range.Your AST and ALT levels in your blood are not more than 3 times the upper limit of normal.Your albumin levels are 2.8 grams per deciliter or higher.Your potassium levels are normal.Normal phosphorus levels.My cancer cannot be removed by surgery and has spread.My cancer is a neuroendocrine tumor from the pancreas, GI tract, lung, thymus, or an unknown site.My tumor may or may not be affecting my body's functions.My cancer can be measured on a scan.My cancer is a neuroendocrine tumor from the pancreas, GI tract, lung, or an unknown primary site.My scans show my cancer has grown or spread in the last year.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.My tumor is a well- or moderately-differentiated neuroendocrine tumor.I have not had severe heart failure in the last 6 months.I haven't had serious heart rhythm problems in the last 6 months.Your magnesium levels are within the normal range.I haven't had any cancer, except for skin cancer, in the last 5 years.I am currently taking medication to prevent blood clots.I am not on any strong CYP3A4 inhibitors.I am not on any strong medications that affect liver enzymes.I haven't had a heart attack or unstable chest pain in the last 6 months.My blood pressure has been stable for the last 2 weeks.I haven't had serious stomach or intestine problems that could cause bleeding in the last 6 months.I haven't had any non-healing wounds or ulcers in the last 28 days.My brain metastases are treated, stable, and I haven't used steroids in 4 weeks.I do not have any active cancer except for non-melanoma skin cancer or cervical carcinoma in situ.My bilirubin levels are normal, except if I have Gilbert's syndrome, where it can be up to 3 times the normal limit.I am able to get out of my bed or chair and move around.My tumor may or may not cause hormone-related symptoms.The amount of protein in your urine compared to creatinine is less than or equal to 1.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal.I am not planning to use other experimental treatments or cancer therapies while in this study.My kidney function is normal or only slightly reduced.Your heart's QT interval, adjusted for your heart rate, should be less than or equal to 500 milliseconds.I do not have any signs of pancreatitis.I haven't had blood clots in the last 6 months.I have not had any fractures in the last 28 days.Your hemoglobin level is 9 grams per deciliter or higher.I have not coughed up more than a small amount of blood in the last 3 months.Thyroid-stimulating hormone (TSH) is within normal limits.Your absolute neutrophil count is at least 1,500 per cubic millimeter.My scans show my cancer has grown in the last year.My lung cancer has not spread to the main airways or blood vessels.Your blood clotting time is within a certain range considered normal.My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.
- Group 1: Arm I (cabozantinib S-malate)
- Group 2: Arm II (placebo)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the most common diseases that Cabozantinib S-malate is used to manage?
"Cabozantinib S-malate is most frequently utilized as a treatment for patients who have already undergone anti-vegf therapy. Additionally, it can be effective in treating advanced renal cell carcinoma (arcc), adrenal medulla, and high risk patients."
Are there other instances where Cabozantinib S-malate has been used in research?
"First investigated in 2012 at Memorial Sloan Kettering Commack, cabozantinib s-malate has had 728 completed clinical studies. As of now, there are 116 active trials underway; a large number of which are based in Decatur, Illinois."
Are people with the required health qualifications still able to join this clinical trial?
"The clinical trial is still recruiting patients, according to the information on clinicaltrials.gov. This study was posted on July 18th, 2018 and updated November 4th, 2022. They are looking for 395 participants total, at 100 different sites."
Does the FDA recognize Cabozantinib S-malate as an official medication?
"There is some evidence of cabozantinib s-malate's efficacy, as well as several rounds of data affirming its safety. Consequently, it received a score of 3."
Is this research novel in terms of its methodology or conclusions?
"Since the first clinical trial in 2012, there have been a total of 728 studies conducted for Cabozantinib S-malate across 46 countries and 1375 cities. The initial study, sponsored by Exelixis, was completed in 2012 with 86 patients and it achieved Phase 2 drug approval."
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