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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
Low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes: carcinoid tumor, low- to intermediate-grade or well- to moderately-differentiated neuroendocrine carcinoma or tumor, atypical carcinoid tumor; documentation from a primary tumor or metastatic site is sufficient; patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible
Locally unresectable or metastatic carcinoid tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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 below
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My cancer is a low or intermediate-grade neuroendocrine type, not high-grade or poorly differentiated.
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My cancer cannot be removed by surgery and may have spread.
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My cancer has worsened in the last year, even with treatment.
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My cancer can be measured by scans and is at least 1 cm in size.
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My cancer is a low- or intermediate-grade neuroendocrine type.
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My cancer cannot be removed by surgery and may have spread.
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I have a confirmed carcinoid tumor.
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My scans show my cancer has worsened in the last year.
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I have never been treated with drugs that target VEGF or VEGFR.
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My blood pressure is under control.
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I do not have irregular heartbeats or prolonged QTc.
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I am fully active or can carry out light work.
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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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I haven't had a clot in my arteries in the last 6 months.
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I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last month.
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I have completed all required surgeries within the specified time.
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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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My cancer has not spread to my brain or spinal cord.
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I stopped taking strong CYP3A4 inhibitors 2 weeks before starting the study treatment.
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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 haven't had any unusual bleeding or coughing up blood in the last 8 weeks.
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I have been on a stable blood thinner for at least 6 weeks.
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I have not had heart failure symptoms in the last 6 months.
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I am 18 years old or older.
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I do not have unstable heart pain or uncontrolled irregular heartbeats.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Other outcome measures
Biochemical Response
PFS Within Each Arm

Side effects data

From 2016 Phase 2 trial • 22 Patients • NCT01247571
79%
Nausea
74%
Fatigue
68%
Diarrhea
53%
White Blood Cell Decreased
53%
Neutrophil Count Decreased
53%
Hypertension
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%
Blurred Vision
16%
Blood Bilirubin Increased
16%
Dysphagia
16%
Dry Mouth
16%
Alkaline Phosphatase Increased
16%
Hypomagnesemia
16%
Hypocalcemia
16%
Arthralgia
16%
Memory Impairment
16%
Insomnia
16%
Epistaxis
11%
Rectal Hemorrhage
11%
Gastroesophageal Reflux Disease
11%
Creatinine Increased
11%
Hearing Impaired
11%
Tinnitus
11%
Platelet Count Decreased
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%
Sinus Bradycardia
5%
Sinus Tachycardia
5%
Sepsis
5%
Gastrointestinal Pain
5%
Edema Trunk
5%
Investigations - Other
5%
Proctitis
5%
Oral Pain
5%
Flatulence
5%
Urinary Tract Infection
5%
Reproductive System And Breast Disorders - Other
5%
Ascites
5%
Dyspepsia
5%
Lymphocyte Count Decreased
5%
Bruising
5%
Ear Pain
5%
Pain
5%
Fever
5%
Mucositis Oral
5%
Death Nos
5%
Bloating
5%
Edema Limbs
5%
Sinusitis
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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 1
~1850
Computed Tomography
2017
Completed Phase 2
~2710
Pazopanib Hydrochloride
2009
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,586 Previous Clinical Trials
41,242,028 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,452 Patients Enrolled for Neuroendocrine Tumors
Emily K BergslandPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Pazopanib Hydrochloride (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01841736 — Phase 2
Neuroendocrine Tumors Research Study Groups: Arm II (placebo), Arm I (pazopanib hydrochloride)
Neuroendocrine Tumors Clinical Trial 2023: Pazopanib Hydrochloride Highlights & Side Effects. Trial Name: NCT01841736 — Phase 2
Pazopanib Hydrochloride (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01841736 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment period still open for this research trial?

"At the moment, this trial is not open for recruitment. Initially posted on June 21st 2013 and last edited on September 23rd 2022, any hopeful participants should look to 3502 other studies enrolling cancer patients or 24 trials that use Pazopanib Hydrochloride as an intervention."

Answered by AI

What is the total capacity of this medical trial?

"At the current moment, this research project is not seeking any additional volunteers. The first posting of said study was on June 21st 2013 and it has since been updated last September 23rd 2022. If you are looking for other clinical trials to take part in, there are 3502 cancer studies currently enrolling participants and 24 active investigations that involve Pazopanib Hydrochloride."

Answered by AI

Does this trial feature a novel approach or strategy?

"Since 2011, Pazopanib Hydrochloride has been under investigation. The initial trial was sponsored by Novartis in 2011 and included 180 participants. Following this first study, the drug achieved its Phase 2 approval for use. Currently there are 24 active studies within 23 countries across 608 cities involving this medication."

Answered by AI

What is the geographical extent of this experimental research?

"At the moment, this study is recruiting patients from a total of 100 centres. These are mostly located in Kansas City, Saint Joseph and Milwaukee but there are also other sites that potential participants can attend. To reduce transportation needs, it would be prudent to select a clinic closest you."

Answered by AI

Are there any previous trials that have examined the efficacy of Pazopanib Hydrochloride?

"Pazopanib Hydrochloride has had a long history of clinical research, beginning at the University of Texas MD Anderson Cancer Center in 2011. 807 trials have successfully concluded to date and there are presently 24 active studies underway, with many taking place around Kansas City, Kansas."

Answered by AI

What potential risks can individuals incur from taking Pazopanib Hydrochloride?

"Given the lack of efficacy data, but presence of safety data, our team at Power awarded Pazopanib Hydrochloride a score of 2 on our 1 to 3 scale."

Answered by AI
~15 spots leftby Feb 2025