Evaluation of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases
- Sponsor
- Centre Leon Berard
- Study ID
- NCT03967522
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cabozantinib — DRUGAll participants will be treated by 60 mg of cabozantinib once daily. Temporary or permanent discontinuation and/or dose reduction of cabozantinib therapy may be required for the management of some adverse reactions. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
Study Details
This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC).
Key Dates
- Start date
- Nov 29, 2019
- Status verified
- Aug 2025
- Primary completion
- Oct 22, 2024
- Completion
- Nov 1, 2024
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cabozantinib treatmentAll participants will be treated by 60 mg of cabozantinib once daily.
Primary Outcome Measure
The non progression rate in brain metastases at 6 months [ Time Frame: At 6 months for each patient ]
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