A Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in GEP and NET

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT04427787
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Cabozantinib will be administered orally at a dose of 60 mg/day
  • Lanreotide — DRUG
    Lanreotide will be administrated 120 mg injection every 28 days

Study Details

A Phase II trial aiming to assess the safety and activity of the combination of cabozantinib plus lanreotide in gastroenteropancreatic (GEP) and thoracic neuroendocrine tumor (NET): The LOLA trial

Key Dates

Start date
Jun 20, 2020
Status verified
Sep 2021
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

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

Arms

  • Experimental: Cabozantinib+lanreotide
    Cabozantinib will be administered orally at a dose of 60 mg/day continuously in combination with Lanreotide 120 mg injection every 28 days. Both treatments will start the same day

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 42 months ]

Central Contacts

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