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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 60 months

Awards & highlights

Pivotal Trial

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.

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.

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 below

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I do not have a history of inherited long QT syndrome.

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I have not had a GI perforation in the last 6 months.

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My cancer has not spread to or around any major blood vessels.

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I am 18 years old or older.

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My condition worsened or I couldn't tolerate my previous FDA-approved treatment.

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My tumor has not invaded my digestive system, risking perforation or bleeding recently.

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I can swallow pills without any issues.

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My cancer cannot be removed by surgery and has spread.

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My cancer is a neuroendocrine tumor from the pancreas, GI tract, lung, thymus, or an unknown site.

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My cancer can be measured on a scan.

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My tumor is a well- or moderately-differentiated neuroendocrine tumor.

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I have not had severe heart failure in the last 6 months.

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I haven't had serious heart rhythm problems in the last 6 months.

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I haven't had serious stomach or intestine problems that could cause bleeding in the last 6 months.

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I haven't had any non-healing wounds or ulcers in the last 28 days.

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I do not have any active cancer except for non-melanoma skin cancer or cervical carcinoma in situ.

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I am able to get out of my bed or chair and move around.

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I am not planning to use other experimental treatments or cancer therapies while in this study.

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My kidney function is normal or only slightly reduced.

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I do not have any signs of pancreatitis.

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I have not had any fractures in the last 28 days.

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My lung cancer has not spread to the main airways or blood vessels.

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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:

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My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I am currently taking medication to prevent blood clots.

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I am not on any strong CYP3A4 inhibitors.

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I am not on any strong medications that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Number of Patients Experiencing Grade 3+ 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 • NCT02315430

85%

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%

Sore Throat

15%

Activated Partial Thromboplastin Time Prolonged

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

Allergic Rhinitis

Generalized Muscle Weakness

Creatinine Increased

Hyponatremia

Flank Pain

Bone Pain

Gastroesophageal Reflux Disease

Chest Pain - Cardiac

Vertigo

Neutrophil Count Decreased

Arthralgia

Syncope

Proteinuria

Pleural Effusion

Nasal Congestion

Pleuritic Pain

Hoarseness

Nail Discoloration

Ventricular Tachycardia

Tinnitus

Gastrointestinal Pain

Floaters

Dysphagia

Blood Bilirubin Increased

Lung Infection

Fever

Depression

Hypersomnia

Hypotension

Productive Cough

Memory Impairment

Anxiety

Cardiac Troponin I Increased

Urinary Incontinence

Pancreatitis

Upper Respiratory Infection

Bruising

Weight Gain

Skin Induration

100%

80%

60%

40%

20%

Study treatment Arm

Cabozantinib

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1180

Cabozantinib S-malate

2013

Completed Phase 2

~590