Cabozantinib in High Grade Neuroendocrine Neoplasms

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04412629
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • High Grade Neuroendocrine Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Cabozantinib should be taken on an empty stomach (at least 1 hour before or 2 hours after eating) at the same time every day.
  • Blood for plasma biomarkers — PROCEDURE
    Baseline, cycle 1 day 8, cycle 1 day 15, and day 1 of every cycle thereafter
  • Tissue biopsy — PROCEDURE
    Baseline, before start of cycle 2, and time of progression

Study Details

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.

Key Dates

Start date
Nov 24, 2020
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    -Cabozantinib 60 mg by mouth daily on days 1-21

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Through the end of treatment (estimated to be 4 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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