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Tyrosine Kinase Inhibitor

Cabozantinib for Neuroendocrine Cancer

Phase 2

Recruiting

Led By Nikolaos Trikalinos, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed high-grade neuroendocrine tumor that has progressed after at least one line of therapy, excluding small cell lung cancer (SCLC)

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 1 year)

Awards & highlights

Study Summary

This trial is testing a new chemotherapy regimen for neuroendocrine neoplasm patients who have relapsed after first-line treatment.

Who is the study for?

Adults with high-grade neuroendocrine tumors that have worsened after first-line therapy can join this trial. They must not have small cell lung cancer, be in good physical condition, and agree to use contraception. Pregnant or breastfeeding women, those who've had cabozantinib before, recent major surgery or other cancer treatments are excluded.Check my eligibility

What is being tested?

The trial tests Cabozantinib's effectiveness on neuroendocrine tumors. Participants will also undergo tissue biopsies and blood tests for biomarkers. The goal is to find better treatment options since current second- and third-line therapies lack consensus.See study design

What are the potential side effects?

Cabozantinib may cause side effects like fatigue, high blood pressure, hand-foot skin reactions (redness and peeling), gastrointestinal symptoms (diarrhea, nausea), abnormal liver enzyme levels, decreased appetite and weight loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My high-grade neuroendocrine tumor has worsened after treatment, but it's not small cell lung cancer.

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I am 18 years old or older.

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I am not pregnant and can become pregnant.

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My blood, liver, and kidneys are functioning well.

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I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Overall survival (OS)

Progression-free survival (PFS)

Safety of regimen as measured by incidence of adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: CabozantinibExperimental Treatment3 Interventions

-Cabozantinib 60 mg by mouth daily on days 1-21

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tissue biopsy

2017

N/A

~10

Cabozantinib

2020

Completed Phase 2

~1080

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,774 Total Patients Enrolled

ExelixisIndustry Sponsor

117 Previous Clinical Trials

19,519 Total Patients Enrolled

Nikolaos Trikalinos, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04412629 — Phase 2

Neuroendocrine Carcinoma Research Study Groups: Cabozantinib

Neuroendocrine Carcinoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04412629 — Phase 2

Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04412629 — Phase 2

Frequently Asked Questions

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

How many test subjects are required for this clinical trial?

"Correct, the clinical trial is still recruiting patients according to the latest information on clinicaltrials.gov. This page was originally created on November 24th 2020 and was edited as recently as November 16th 2022. They are currently looking for 32 people to fill 1 spot(s)."

Answered by AI

Could you please expand on the potential side effects of Cabozantinib?

"Cabozantinib is in Phase 2 of clinical trials, meaning there is some data supporting its safety but none yet confirming its efficacy. Our team at Power gives it a safety rating of 2."

Answered by AI

Has this type of research been conducted before?

"Currently, there are 116 clinical trials for the drug cabozantinib being conducted in 1375 cities and 46 countries. The initial study for this drug was completed in 2012 and involved 86 participants. This study reached Phase 2 approval and since then, 56 more trials have been conducted."

Answered by AI

What condition does Cabozantinib help patients with?

"Cabozantinib is a medication that is typically used to treat patients who have previously been treated with anti-VEGF therapy. It can also be effective in treating multiple other conditions, such as advanced renal cell carcinoma (ARCC), adrenal medulla, and high risk patients."

Answered by AI

Are there any available spots for participants in this clinical trial?

"This clinical trial, as reported on clinicaltrials.gov, is currently seeking patients. The trial was initially posted on 11/24/2020 and was most recently updated on 11/16/2022."

Answered by AI

Are there any other ongoing investigations with Cabozantinib?

"There are 116 clinical trials evaluating the efficacy of Cabozantinib, 13 of which are in Phase 3. Most investigations for this medication are taking place Cordoba and Calabria, but there are 7151 total locations running these tests."

Answered by AI

Recent research and studies

PancreasJournal

Abstracts Presented at the 13th Annual Multidisciplinary Neuroendocrine Tumor Medical Virtual Symposium of the North American Neuroendocrine Tumor Society, October 2-3, 2020

“Abstracts Presented at the 13th Annual Multidisciplinary Neuroendocrine Tumor Medical Virtual Symposium of the North American Neuroendocrine Tumor Society, October 2-3, 2020”. 2021. “Abstracts Presented at the 13th Annual Multidisciplinary Neuroendocrine Tumor Medical Virtual Symposium of the North American Neuroendocrine Tumor Society, October 2-3, 2020”. Pancreas. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpa.0000000000001763.

clinicaltrials.govStudy

Cabozantinib in High Grade Neuroendocrine Neoplasms

2020. "Cabozantinib in High Grade Neuroendocrine Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04412629.

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