NCT04412629

Cabozantinib in High Grade Neuroendocrine Neoplasms

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-11-24
• Primary completion: 2026-09-30
• Completion: 2027-03-31
• First posted: 2020-06-02
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study