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Tyrosine Kinase Inhibitor
Pazopanib for Carcinoid Tumor
Phase 2
Waitlist Available
Led By Emily K Bergsland
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 prior treatment with an inhibitor of VEGF or VEGFR
Age >= 18 years
Must not have
Symptomatic peripheral vascular disease
INR > 1.2 X ULN for patients receiving anticoagulant therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing how well pazopanib hydrochloride works in treating patients with carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
Adults with low or intermediate-grade neuroendocrine carcinoid tumors that can't be surgically removed or have spread, and show signs of progression. Participants must not have high-grade variants, significant recent cardiovascular issues, uncontrolled blood pressure, bleeding risks, immune compromise conditions, or certain gastrointestinal problems. Pregnant women and those on strong CYP3A4 inhibitors are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Pazopanib Hydrochloride in slowing down or stopping tumor growth compared to a placebo. It's randomized and includes various assessments like echocardiography and MRI to monitor heart function and tumor changes.See study design
What are the potential side effects?
Pazopanib may cause liver issues (elevated liver enzymes), heart problems (high blood pressure, decreased heart function), risk of bleeding events (hemorrhage), fatigue, diarrhea, nausea, hair color change, loss of appetite.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never been treated with drugs that target VEGF or VEGFR.
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I am 18 years old or older.
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I have a confirmed carcinoid tumor.
Select...
My cancer can be measured by scans and is at least 1 cm in size.
Select...
My cancer is a low or intermediate-grade neuroendocrine type, not high-grade or poorly differentiated.
Select...
My cancer has worsened in the last year, even with treatment.
Select...
My cancer cannot be removed by surgery and may have spread.
Select...
I have not had heart failure symptoms in the last 6 months.
Select...
I do not have irregular heartbeats or prolonged QTc.
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My cancer is a low- or intermediate-grade neuroendocrine type.
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My blood clotting test results are within the normal range, even though I'm on blood thinners.
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My cancer has not spread to my brain or spinal cord.
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I do not have unstable heart pain or uncontrolled irregular heartbeats.
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I haven't had serious stomach or intestine problems in the last month.
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I am not pregnant.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have symptoms of poor blood flow in my limbs.
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My blood clotting time is slightly higher due to my anticoagulant medication.
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My lung cancer affects the airways or blood vessels in my lungs.
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I haven't had serious wounds, ulcers, injuries, or broken bones in the last 28 days.
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I have had a condition where my lymphocytes grow abnormally.
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My cancer has spread to the large blood vessels of my lungs.
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I have large growths in the main airways of my lungs.
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I have a condition that weakens my immune system.
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I am not on any strong CYP3A4 inhibitors.
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I do not have unstable heart pain or uncontrolled irregular heartbeats.
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I have a history of cancer.
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My cancer is a specific type of aggressive neuroendocrine tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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
Best Response
Duration of Response for the Subset of Patients With a Confirmed Complete Response or Partial Response
Overall Survival
+2 moreOther outcome measures
Biochemical Response
PFS Within Each Arm
Side effects data
From 2016 Phase 2 trial • 22 Patients • NCT0124757179%
Nausea
74%
Fatigue
68%
Diarrhea
53%
Neutrophil Count Decreased
53%
Hypertension
53%
White Blood Cell Decreased
47%
Anemia
42%
Vomiting
42%
Peripheral Sensory Neuropathy
37%
Constipation
37%
Abdominal Pain
32%
Anorexia
32%
Headache
32%
Dyspnea
26%
Cough
21%
Weight Loss
21%
Alopecia
21%
Alanine Aminotransferase Increased
21%
Hyponatremia
21%
Hypoalbuminemia
21%
Pain In Extremity
21%
Depression
21%
Aspartate Aminotransferase Increased
16%
Dry Mouth
16%
Blurred Vision
16%
Dysphagia
16%
Blood Bilirubin Increased
16%
Alkaline Phosphatase Increased
16%
Hypomagnesemia
16%
Hypocalcemia
16%
Arthralgia
16%
Memory Impairment
16%
Insomnia
16%
Epistaxis
11%
Hearing Impaired
11%
Creatinine Increased
11%
Platelet Count Decreased
11%
Tinnitus
11%
Gastroesophageal Reflux Disease
11%
Rectal Hemorrhage
11%
Hypokalemia
11%
Hypoglycemia
11%
Hyperglycemia
11%
Neck Pain
11%
Generalized Muscle Weakness
11%
Dizziness
11%
Anxiety
11%
Vaginal Hemorrhage
11%
Vaginal Discharge
11%
Rash Maculo-Papular
11%
Skin Hypopigmentation
11%
Urinary Frequency
5%
Reproductive System And Breast Disorders - Other
5%
Edema Trunk
5%
Death Nos
5%
Dyspepsia
5%
Ear Pain
5%
Sepsis
5%
Sinus Tachycardia
5%
Bloating
5%
Proctitis
5%
Oral Pain
5%
Ascites
5%
Edema Limbs
5%
Bruising
5%
Investigations - Other
5%
Sinus Bradycardia
5%
Urinary Tract Infection
5%
Mucositis Oral
5%
Gastrointestinal Pain
5%
Flatulence
5%
Fever
5%
Sinusitis
5%
Lymphocyte Count Decreased
5%
Pain
5%
Dehydration
5%
Back Pain
5%
Arthritis
5%
Paresthesia
5%
Dysgeusia
5%
Urinary Retention
5%
Pelvic Pain
5%
Allergic Rhinitis
5%
Skin And Subcutaneous Tissue Disorders - Other
5%
Nail Discoloration
5%
Dry Skin
5%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pazopanib
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (pazopanib hydrochloride)Experimental Treatment9 Interventions
Patients receive pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.
Group II: Arm II (placebo)Placebo Group9 Interventions
Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Biospecimen Collection
2004
Completed Phase 2
~1720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Pazopanib Hydrochloride
2009
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,230 Total Patients Enrolled
80 Trials studying Neuroendocrine Tumors
43,427 Patients Enrolled for Neuroendocrine Tumors
Emily K BergslandPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms of poor blood flow in my limbs.Your heart's pumping ability is strong (ejection fraction > 50%).My blood clotting time is slightly higher due to my anticoagulant medication.Your bilirubin levels are higher than 1.5 times the normal limit.I am 18 years old or older.My scans show my cancer has worsened in the last year.You have a detectable disease that can be seen on a CT scan or MRI according to specific guidelines.I have never been treated with drugs that target VEGF or VEGFR.You have evidence of cancer spreading to the brain at the start of the study.Your heart takes too long to recharge between beats.Your blood test shows creatinine levels higher than 1.5 times the normal range.Your urine protein level is too high.My cancer is a low or intermediate-grade neuroendocrine type, not high-grade or poorly differentiated.Your blood creatinine level is not higher than 1.5 times the upper limit of normal.My cancer has spread to the large blood vessels of my lungs.I have large growths in the main airways of my lungs.I have a condition that weakens my immune system.I have a carcinoid tumor not suspected to be specific excluded types, with or without symptoms, and it has worsened after PRRT treatment completed over 8 weeks ago.My lung cancer does not involve major blood vessels or large airways.Your platelet count is at least 100,000 per microliter.I have a confirmed carcinoid tumor.Your AST and ALT blood test results must be less than or equal to 2.5 times the upper limit of normal.Your urine protein level is less than a certain amount.My blood clotting test results are within the normal range, even though I'm on blood thinners.My cancer has not spread to my brain or spinal cord.My cancer can be measured by scans and is at least 1 cm in size.I haven't had any cancer except for skin cancer in the last 5 years.My lung cancer affects the airways or blood vessels in my lungs.I haven't had serious wounds, ulcers, injuries, or broken bones in the last 28 days.My cancer has worsened in the last year, even with treatment.I have had a condition where my lymphocytes grow abnormally.I haven't had major stomach or intestine issues in the last 28 days.I have had symptoms of heart failure in the last 6 months.I am not on any strong CYP3A4 inhibitors.My cancer cannot be removed by surgery and may have spread.I haven't had serious wounds, ulcers, injuries, or broken bones in the last 28 days.I have not had heart failure symptoms in the last 6 months.I do not have irregular heartbeats or prolonged QTc.I stopped taking strong CYP3A4 inhibitors 2 weeks before starting the study treatment.I have not had a clot in my arteries in the last 6 months.I do not have unstable heart pain or uncontrolled irregular heartbeats.My cancer is a low- or intermediate-grade neuroendocrine type.I have been on a stable blood thinner for at least 6 weeks.I haven't had any unusual bleeding or coughing up blood in the last 8 weeks.I do not have unstable heart pain or uncontrolled irregular heartbeats.Your thyroid-stimulating hormone (TSH) levels are normal.I have a history of cancer.My cancer is a specific type of aggressive neuroendocrine tumor.Your AST and ALT levels in your blood are more than 2.5 times higher than the upper limit of normal.I haven't had a clot in my arteries in the last 6 months.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last month.I have not had any major abdominal issues like a fistula, perforation, or abscess in the last 28 days.Your heart's pumping ability is less than 50% according to a specific heart test.Your thyroid-stimulating hormone (TSH) levels are not in the normal range.I have completed all required surgeries within the specified time.I haven't had serious stomach or intestine problems in the last month.You have a healthy amount of a type of white blood cell called granulocytes.I am not pregnant.My blood pressure is under control.I am fully active or can carry out light work.You have a low number of granulocytes in your blood.Your platelet count is less than 100,000 per microliter.Your heart's electrical activity should be within a certain range (less than or equal to 480 milliseconds).Your bilirubin level must be less than or equal to 1.5 times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (placebo)
- Group 2: Arm I (pazopanib hydrochloride)
Awards:
This trial has 0 awards, including: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.
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