Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Cabozantinib for Pancreatic Neuroendocrine Tumors
Phase 3
Waitlist Available
Led By Jennifer A Chan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No known history of congenital long QT syndrome
No GI perforation within 6 months of registration
Must not have
Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma without specification of differentiation status, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible
History of any lymphoproliferative disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
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.
Who is the study for?
Adults with advanced neuroendocrine or carcinoid tumors that have spread and worsened after prior therapy can join. They must be able to swallow pills, not pregnant, no severe allergies to similar drugs as cabozantinib/placebo, and have a decent performance status (able to carry out daily activities). People with certain heart conditions, uncontrolled blood pressure, recent bleeding or clotting events, or other cancers within the last 5 years cannot participate.Check my eligibility
What is being tested?
This phase III trial is testing if cabozantinib works better than a placebo for treating advanced neuroendocrine or carcinoid tumors. Cabozantinib is a chemotherapy drug that blocks specific receptors which may slow tumor growth. Patients will also undergo scans and quality-of-life assessments.See study design
What are the potential side effects?
Cabozantinib might cause high blood pressure, tiredness, mouth sores, hand-foot skin reactions, loss of appetite and weight loss. It could also lead to diarrhea or constipation and increase the risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have a history of inherited long QT syndrome.
Select...
I have not had a GI perforation in the last 6 months.
Select...
My cancer has not spread to or around any major blood vessels.
Select...
I am 18 years old or older.
Select...
My condition worsened or I couldn't tolerate my previous FDA-approved treatment.
Select...
My tumor has not invaded my digestive system, risking perforation or bleeding recently.
Select...
I can swallow pills without any issues.
Select...
My cancer cannot be removed by surgery and has spread.
Select...
My cancer is a neuroendocrine tumor from the pancreas, GI tract, lung, thymus, or an unknown site.
Select...
My cancer can be measured on a scan.
Select...
My tumor is a well- or moderately-differentiated neuroendocrine tumor.
Select...
I have not had severe heart failure in the last 6 months.
Select...
I haven't had serious heart rhythm problems in the last 6 months.
Select...
I haven't had serious stomach or intestine problems that could cause bleeding in the last 6 months.
Select...
I haven't had any non-healing wounds or ulcers in the last 28 days.
Select...
I do not have any active cancer except for non-melanoma skin cancer or cervical carcinoma in situ.
Select...
I am able to get out of my bed or chair and move around.
Select...
I am not planning to use other experimental treatments or cancer therapies while in this study.
Select...
My kidney function is normal or only slightly reduced.
Select...
I do not have any signs of pancreatitis.
Select...
I have not had any fractures in the last 28 days.
Select...
My lung cancer has not spread to the main airways or blood vessels.
Select...
My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.
Select...
I have had a condition where my lymphocytes grow abnormally.
Select...
I have a history of cancer.
Select...
I am currently taking medication to prevent blood clots.
Select...
I am not on any strong CYP3A4 inhibitors.
Select...
I am not on any strong medications that affect liver enzymes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Incidence of adverse events (AEs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Overall survival (OS)
Radiographic response rate
Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Activated Partial Thromboplastin Time Prolonged
15%
Sore Throat
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Allergic Rhinitis
8%
Generalized Muscle Weakness
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (cabozantinib S-malate)Experimental Treatment5 Interventions
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study.
Group II: Arm II (placebo)Placebo Group5 Interventions
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,105 Total Patients Enrolled
Jennifer A ChanPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (cabozantinib S-malate)
- Group 2: Arm II (placebo)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger