CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 298 enrolled / 298 target
Drug / intervention
Cabozantinib S-malate +6 moredrug
Likely dose
Cabozantinib S-malate orally once daily on days 1-28 of each 28-day cycle (specific dose not stated in arms section)AI-extracted
Key inclusion· 8
  • ✓Histologically confirmed well- or moderately-differentiated neuroendocrine tumor (or low/intermediate-grade NET or carcinoid) of pancreatic, gastrointestinal, lung, thymus, or unknown primary site
  • ✓Locally advanced/unresectable or metastatic disease with evidence of progression by RECIST 1.1 within 12 months prior to registration
  • ✓Measurable disease per RECIST 1.1 with lesions ≥1 cm by CT/MRI (or ≥1.5 cm for lymph nodes)
  • ✓Prior progression or intolerance to at least one FDA-approved line of therapy; specific prior therapy required depends on tumor type (pancreatic: everolimus, sunitinib, or lutetium Lu 177 dotatate; lung: everolimus; gastrointestinal: everolimus or lutetium Lu 177 dotatate)
Key exclusion· 30
  • ✕Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, or goblet cell carcinoid (except well-differentiated grade 3 NETs which are eligible)
  • ✕Prior treatment with cabozantinib
  • ✕Class III or IV congestive heart failure within 6 months
  • ✕Clinically significant cardiac arrhythmia within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03375320
NCT03375320Phase 3ActiveUpdate Overdue (3.2/mo)Completion was 34mo ago
CompareCT.gov

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients With Advanced NEuroendocrine Tumors After Progression on Prior Therapy (CABINET)

National Cancer Institute (NCI)·interventional·Posted Dec 18, 2017·Updated Jun 11, 2026

In Brief

A Phase 3 clinical trial evaluating Biospecimen Collection, Cabozantinib S-malate, and 5 other interventions for Functioning Pancreatic Neuroendocrine Tumor and 27 related conditions. Active but no longer recruiting, targeting 298 participants across 433 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm, Locally Advanced Digestive System Neuroendocrine Neoplasm, Locally Advanced Digestive System Neuroendocrine Tumor G1, Locally Advanced Lung Neuroendocrine Neoplasm, Locally Advanced Pancreatic Neuroendocrine Tumor, Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm, Low Grade Lung Neuroendocrine Neoplasm, Lung Neuroendocrine Tumor, Lung Neuroendocrine Tumor G2, Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Lung Neuroendocrine Neoplasm, Metastatic Lung Neuroendocrine Tumor, Metastatic Pancreatic Neuroendocrine Neoplasm, Metastatic Pancreatic Neuroendocrine Tumor, Metastatic Thymus Neuroendocrine Neoplasm, Neuroendocrine Neoplasm, Neuroendocrine Tumor, Neuroendocrine Tumor G2, Non-Functioning Pancreatic Neuroendocrine Tumor, Pancreatic Serotonin-Producing Neuroendocrine Tumor, Thymus Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Neoplasm, Unresectable Digestive System Neuroendocrine Tumor G1, Unresectable Lung Neuroendocrine Neoplasm, Unresectable Pancreatic Neuroendocrine Neoplasm, Unresectable Thymus Neuroendocrine Neoplasm
CountriesUnited States
Collaborators--

Timeline

Phase 3Active
201820192020202120222023202420252026
First PostedDec 18, 2017
Enrollment StartOct 26, 2018
Primary CompletionAug 23, 2023
Study CompletionAug 19, 2026
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.5 years ago

Arms & Interventions

Arm I (cabozantinib S-malate)experimental

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 blood and urine sample collection, and CT, MRI, and/or x-ray imaging during screening and on study.

Procedure: Biospecimen CollectionDrug: Cabozantinib S-malateProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingOther: Quality-of-Life AssessmentProcedure: X-Ray Imaging
Arm II (placebo)placebo_comparator

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 blood and urine sample collection, and 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.

Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingOther: Placebo AdministrationOther: Quality-of-Life AssessmentProcedure: X-Ray Imaging

Interventions

Biospecimen Collectionprocedure

Undergo blood and urine sample collection

Cabozantinib S-malatedrug

Given PO

Computed Tomographyprocedure

Undergo CT

Magnetic Resonance Imagingprocedure

Undergo MRI

Placebo Administrationother

Given PO

Quality-of-Life Assessmentother

Ancillary studies

X-Ray Imagingprocedure

Undergo x-ray