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Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

An Open-Label, Phase II Study of Cabozantinib (XL184) in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

NCT01466036•Dana-Farber Cancer Institute

Summary

Cabozantinib works by blocking the growth of new blood vessels that feed a tumor. In addition to blocking the formation of new blood cells in tumors, cabozantinib also blocks pathways that may be responsible for allowing cancers cells to become resistant to other "anti-angiogenic" drugs. Cabozantinib has been studied or is being study in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer, and kidney cancer. In this research study, the investigators wish to learn if cabozantinib is effective in treating patients with pancreatic neuroendocrine and carcinoid tumors.

Detailed Description

Subjects will take cabozantinib orally, once per day, in cycles of 28 days. During each cycle subjects will have the following procedures: * Physical examination, including measurement of weight and vital signs * Questions regarding any side effects * Blood sample (about 1 tablespoon) for routine laboratory tests of blood cell counts, blood chemistries, organ function and blood clotting * Blood sample (about 4 tablespoons) for research test to measure biomarkers to assess the response to study drug * Urine sample for routine urine tests to monitor health On Day 15 (beginning of week 3) during the first 3 cycles: * Physical examination, including measurement of weight and vital signs * Questions regarding any side effects * Blood sample (about 1 tablespoon) for routine laboratory tests of blood cell counts, blood chemistries, organ function and blood clotting * Blood sample (about 4 tablespoons) for research test to measure biomarkers to assess the response to study drug Subjects will receive a CT scan or MRI every two cycles (every two months) to evaluate disease.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally unresectable or metastatic, histologically-confirmed, carcinoid or pancreatic neuroendocrine tumor. Tumors must be considered well- or moderately-differentiated. Patients with poorly differentiated neuroendocrine carcinoma or cell carcinoma are excluded from the study.
•A tumor sample is required for enrollment (except for patients diagnosed \> 7 years ago).
•Must have measurable disease by RECIST criteria
•Must have evidence of progressive disease within 12 months of study entry
•Prior or concurrent therapy with somatostatin analogs is permitted. If on somatostatin/octreotide, must be on a stable dose for at least two months.
•Age ≥ 18 years
•No major surgery or radiation in the prior 4 weeks prior to enrollment
•No prior therapy with cabozantinib
•ECOG Performance status ≤ 1
•Participants must have adequate organ and marrow function as defined below:
+10 more criteria

Exclusion Criteria

•Subjects receiving any other standard or investigational anticancer agents, with the exception of somatostatin/octreotide therapy. If patients has received prior cytotoxic chemotherapy, must be at least three weeks since last treatment before first dose of study treatment.
•Major surgery or radiation treatment \<4 weeks prior to enrollment. In addition, cannot have received radiation to the thorax or gastrointestinal tract within three months of the first dose of study treatment.
•Cannot have received radionuclide treatment within 6 weeks of first dose of study treatment.
•High grade or poorly differentiated neuroendocrine tumors
•Ongoing immunosuppression with systemic steroids or other immune modulator
•Presence of CNS metastatic disease
•Uncontrolled hypertension defined by SBP \> 140 or DBP \> 90 despite titration of anti hypertensive medications
•No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements. Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment
•Cerebrovascular accident within prior 6 months
•The subject has a history of clinically significant hematemesis or a recent history of hemoptysis of \> 2.5 mL of red blood or other signs indicative of pulmonary hemorrhage or evidence of endobronchial lesion(s).
+17 more criteria

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

July 1, 2012

Primary Completion Date

August 1, 2021

Completion Date

December 1, 2023

Last Updated

March 5, 2024

Enrollment

ACTUAL participants

Conditions

Carcinoid TumorPancreatic Neuroendocrine Tumor

Interventions

Cabozantinib

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

Inclusion Criteria

Exclusion Criteria

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

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Development of New Personalised 3D Preclinical Models of Pancreatic Neuroendocrine Tumours

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