caBozantinib in Pre-treated pAtients With Metastatic COlorectal Cancer.
NCT06171854 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2024-01-02
Summary
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
Conditions
- Refractory Colorectal Adenocarcinoma
Interventions
- DRUG
-
cabozantinib in patients with refractory mCRC
Sponsors & Collaborators
-
University of Campania Luigi Vanvitelli
lead OTHER
Principal Investigators
-
Erika Martinelli, MD, PhD · [email protected]
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-01
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Italy
Study Locations
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