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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
Must not have
Concomitant anticoagulation with specified agents
Inability to swallow tablets
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 1 year)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking blood thinners.
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I cannot swallow pills.
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I do not have any recent serious illnesses.
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My liver is not working well.
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I have been treated with cabozantinib before.
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My brain metastases or cranial epidural disease has been treated.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Overall survival (OS)
Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2360

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,828 Total Patients Enrolled
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,138 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
~5 spots leftby Jul 2025
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