Study of cabozantinib in renal cell carcinoma with brain metastases

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 77

Inclusion Criteria

I1. Age = 18 years., 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., I2. Histologically proven mRCC, in first line treatment or after one or two prior treatments., I3. Brain metastases not requiring corticosteroids at dose > 40 mg/day., I4. At least 1 locally untreated brain lesion =8 mm in longest diameter or >5 mm 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 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.

Exclusion Criteria

E1. Any local previous treatment of current brain metastases. [Stereotactic radiotherapy or cyberknife on some of the brain metastases is allowed if performed on brain met < 2 cm and at more than 2 weeks before inclusion.], E10. Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient unsuited to study participation., E11. Any second malignancy within the last 3 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months., E12. Patients receiving strong inhibitor or inducer of CYP3A4 especially some anti-epileptic drugs., E13. Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements., E14. Participation to another clinical trial that might interfere with the evaluation of the main criterion., E15. Known hypersensitivity to the active substance or to any of the excipients., E16. Patient requiring tutorship or curatorship., E2. Any anti-coagulation therapy (except preventive treatment at low dose)., E3. Contra-indication for MRI (i.e. pace-maker)., E4. Uncontrolled seizures., E5. Any symptoms of intracranial hypertension., E6. Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack., E7. Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical treatment., E8.Ongoing cardiac dysrhythmia of grade >=2, atrial fibrillation of any grade, QTc interval > 0.43., E9. Pregnant or breast-feeding woman (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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