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Cabozantinib in High Grade Neuroendocrine Neoplasms

NCT04412629 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-06

No results posted yet for this study

Summary

High grade neuroendocrine neoplasm patients are treated with platinum doublets such as carboplatin and etoposide mimicking the current guidelines for small cell lung cancer (SCLC). Unfortunately, recurrences are common and most patients with metastatic disease succumb to it within a year. There is no extensive literature or consensus on second- or third-line options (which include FOLFOX, FOLFIRI, capecitabine and temozolomide, taxanes or immunotherapy) and there is urgent need for better regimens.

Conditions

  • High Grade Neuroendocrine Neoplasms

Interventions

DRUG

Cabozantinib

Cabozantinib should be taken on an empty stomach (at least 1 hour before or 2 hours after eating) at the same time every day.

PROCEDURE

Blood for plasma biomarkers

Baseline, cycle 1 day 8, cycle 1 day 15, and day 1 of every cycle thereafter

PROCEDURE

Tissue biopsy

Baseline, before start of cycle 2, and time of progression

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Nikolaos Trikalinos, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2026-09-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04412629 on ClinicalTrials.gov