Evaluation of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases (NCT03967522) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases
France26 participantsStarted 2019-11-29
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
I1. Age ≥ 18 years. I2. Histologically proven metastatic Renal Cell Carcinoma. I3. Brain metastases not requiring corticosteroids at dose \> 40 mg/day. I4.At least 1 locally untreated brain lesion ≥8mm in longest diameter or \>5mm if \> 1 lesion.
I5.Not previously treated by cabozantinib. I6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1. I7.Life expectancy ≥ 3 months
I8.Adequate organ function as defined by the following criteria:
* Total serum bilirubin ≤ 2 x ULN (Gilbert's disease exempted)
* Serum transaminases and alkaline phosphatases ≤ 2.5 x ULN, or in case of liver or bone metastasis ≤ 5.0 x ULN
* Serum creatinine ≤ 2 x ULN OR creatinine clearance ≥ 50 ml/min
* Absolute neutrophil count (ANC) ≥ 1 500/mm3
* Platelets ≥ 100 000/mm3 (100 G/l)
* Hemoglobin ≥ 9.0 g/dl. I9. Covered by a medical/health insurance. I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
I11. Signed and dated IRB/ICE approved informed consent form. I12. Accepting to use effective contraception (barrier contraceptives) during study treatment and within at least 4 months after final dose of study therapy. Oral contraceptives are not acceptable.
Exclusion Criteria:
E1. Any local previous treatment of current brain metastases. E2. Any anti-coagulation therapy (except preventive treatment at low dose). E3. Contra-indication of Magnetic Resonance Imaging (MRI) (i.e. : pace-maker). E4…
What they're measuring
1
The non progression rate in brain metastases at 6 months