caBozantinib in Pre-treated pAtients With Metastatic COlorectal Cancer.

Sponsor
University of Campania Luigi Vanvitelli
Study ID
NCT06171854
Phase
PHASE2
Status
Unknown

Conditions

  • Refractory Colorectal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    cabozantinib in patients with refractory mCRC

Study Details

This is a phase II non-randomised and non-comparative study, in pretreated mCRC patients, progressed after at least 2 lines of prior chemotherapy for metastatic disease. Treatment plan: * First Stage: A total of 22 patients will be enrolled in the first stage to detect at least 3 patients free of progression at 16 weeks * Second Stage: If at least 3 patients will be free of progression at 16 weeks, an additional cohort of 11 patients will be enrolled in the second stage

Key Dates

Start date
Sep 1, 2019
Status verified
Dec 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: cabozantinib
    60 mg once daily. Route: per os Cycle: 28 days

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 16 weeks ]

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