Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors

Sponsor
National Health Research Institutes, Taiwan
Study ID
NCT05048901
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neuroendocrine Tumors,Gastroenteropancreatic

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Oral Cabozantinib 40-60 mg daily .every 4 weeks as a cycle
  • Lanreotide — DRUG
    Lanreotide 120 mg deep SC on day 1 every 4 weeks.every 4 weeks as a cycle

Study Details

This is an Open-Label Phase I/II Study of daily cabozantinib plus lanreotide every 4 w eeks to treat advanced G1-2 gastroentero-pancreatic neuroendocrine tumor (GEP-NET) patients who failed to one line or more than one line of small molecule kinase inhibitor or well-differentiated (W-D) G3 GEP-NET who failed to one line of small molecule kinase inhibitor or chemotherapy.

Key Dates

Start date
Sep 17, 2021
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib and Lanreotide
    Oral cabozantinib 40-60 mg/day and lanreotide 120mg deep subcutaneous injection (SC) in day 1 every 4 weeks.

Primary Outcome Measure

to determine the maximal tolerated dose of cabozantinib [ Time Frame: Phase I last patient in has been treated for 28 days ]

Central Contacts