Cabozantinib S-malate for Metastatic Pancreatic Neuroendocrine Tumor

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Metastatic Pancreatic Neuroendocrine Tumor+30 MoreCabozantinib S-malate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Metastatic Pancreatic Neuroendocrine Tumor
  • Locally Advanced Digestive System Neuroendocrine Neoplasm
  • Metastatic Lung Carcinoid Tumor
  • Unresectable Lung Neuroendocrine Tumor
  • Unresectable Pancreatic Neuroendocrine Neoplasm
  • Metastatic Pancreatic Neuroendocrine Neoplasm
  • Unresectable Digestive System Neuroendocrine Tumor G1
  • Locally Advanced Digestive System Neuroendocrine Tumor G1
  • Unresectable Digestive System Neuroendocrine Neoplasm
  • Locally Advanced Lung Neuroendocrine Neoplasm
  • Metastatic Lung Neuroendocrine Tumor
  • Thymic Carcinoid Tumor
  • Intermediate Grade Lung Neuroendocrine Neoplasm
  • Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm
  • Metastatic Thymic Neuroendocrine Neoplasm
  • Functioning Pancreatic Neuroendocrine Tumor
  • Non-Functioning Pancreatic Neuroendocrine Tumor
  • Locally Advanced Pancreatic Neuroendocrine Tumor
  • Atypical Carcinoid Tumor
  • Carcinoid Tumor
  • Lung Atypical Carcinoid Tumor
  • Metastatic Digestive System Neuroendocrine Tumor G1
  • Metastatic Digestive System Neuroendocrine Tumor
  • Serotonin-Producing Pancreatic Neuroendocrine Tumor
  • Low Grade Lung Neuroendocrine Tumor
  • Lung Carcinoid Tumor
  • Unresectable Thymic Neuroendocrine Neoplasm
  • Neuroendocrine Tumors
  • Stage IV Digestive System Neuroendocrine Tumor
  • Stage IIIA Digestive System Neuroendocrine Tumor
  • Stage IIIB Digestive System Neuroendocrine Tumor

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 8 years

Year 8
Overall survival (OS)
Year 8
Progression-free survival (PFS)
Up to 8 years
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)
Radiographic response rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Cabozantinib
85%Fatigue
77%Nausea
62%Dysgeusia
62%Vomiting
54%Aspartate Aminotransferase Increased
54%Mucositis Oral
54%Abdominal Pain
54%Alkaline Phosphatase Increased
46%Anorexia
46%Hypertension
38%Weight Loss
38%Alanine Aminotransferase Increased
38%Anemia
38%Diarrhea
38%Constipation
38%Cough
38%Thromboembolic Event
38%Dyspnea
31%Back Pain
31%Hypomagnesemia
31%Lipase Increased
31%Hypoalbuminemia
23%Palmar-Plantar Erythrodysesthesia Syndrome
23%Pain
23%Alopecia
23%Hypophosphatemia
23%Hypothyroidism
23%Oral Pain
23%Hyperglycemia
23%Dizziness
23%Pain In Extremity
23%Headache
15%Platelet Count Decreased
15%Insomnia
15%Sore Throat
15%Abdominal Distension
15%Activated Partial Thromboplastin Time Prolonged
15%White Blood Cell Decreased
15%Myalgia
15%Dry Mouth
15%Dyspepsia
15%Bloating
15%Dehydration
15%Hypocalcemia
15%Dry Skin
15%Flushing
15%Peripheral Sensory Neuropathy
8%Pleural Effusion
8%Bruising
8%Proteinuria
8%Hyponatremia
8%Nasal Congestion
8%Hoarseness
8%Flank Pain
8%Syncope
8%Pleuritic Pain
8%Nail Discoloration
8%Weight Gain
8%Ventricular Tachycardia
8%Pancreatitis
8%Upper Respiratory Infection
8%Creatinine Increased
8%Neutrophil Count Decreased
8%Arthralgia
8%Bone Pain
8%Tinnitus
8%Gastrointestinal Pain
8%Floaters
8%Gastroesophageal Reflux Disease
8%Chest Pain - Cardiac
8%Vertigo
8%Dysphagia
8%Blood Bilirubin Increased
8%Lung Infection
8%Fever
8%Depression
8%Hypersomnia
8%Generalized Muscle Weakness
8%Skin Induration
8%Hypotension
8%Productive Cough
8%Memory Impairment
8%Anxiety
8%Cardiac Troponin I Increased
8%Urinary Incontinence
8%Allergic Rhinitis
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02315430) in the Cabozantinib ARM group. Side effects include: Fatigue with 85%, Nausea with 77%, Dysgeusia with 62%, Vomiting with 62%, Aspartate Aminotransferase Increased with 54%.

Trial Design

2 Treatment Groups

Arm I (cabozantinib S-malate)
1 of 2
Arm II (placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

395 Total Participants · 2 Treatment Groups

Primary Treatment: Cabozantinib S-malate · Has Placebo Group · Phase 3

Arm I (cabozantinib S-malate)Experimental Group · 4 Interventions: Computed Tomography, Cabozantinib S-malate, Laboratory Biomarker Analysis, Quality-of-Life Assessment · Intervention Types: Procedure, Drug, Other, Other
Arm II (placebo)PlaceboComparator Group · 4 Interventions: Placebo Administration, Computed Tomography, Laboratory Biomarker Analysis, Quality-of-Life Assessment · Intervention Types: Other, Procedure, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,128,427 Total Patients Enrolled
2 Trials studying Metastatic Pancreatic Neuroendocrine Tumor
222 Patients Enrolled for Metastatic Pancreatic Neuroendocrine Tumor
Jennifer A ChanPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Tumor Site: Histological documentation of a neuroendocrine tumor (NET) at one of the following locations: the pancreas, gastrointestinal tract (GI), lungs, or an unknown primary site; NETs that occur in the GI tract, lungs, or an unknown primary site will be enrolled in the carcinoid tumor cohort of the study.
to the central IRB The target lesions must have shown evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria in the 12 months prior to registration
The pathology report must state the type of neuroendocrine tumor.
for enrollment Patients with a poorly differentiated neuroendocrine carcinoma, a high-grade neuroendocrine carcinoma, an adenocarcinoid tumor, or a goblet cell carcinoid tumor are not eligible for enrollment.
Result: Partial response Some patients with locally advanced or metastatic disease respond partially to treatment.
to grow and spread, even when they are not associated with a clinical hormone syndrome
that has been performed within 28 days of the first dose of study drug Patients must have measurable, target lesions according to RECIST 1.1 criteria by CT scan or MRI that has been performed within 28 days of the first dose of study drug.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Epic Care-Dublin100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%