CABRAMET - A phase 2 study of cabozantinib in renal cell carcinoma (mRCC) with brain metastases - CABRAMET

Centre Léon Bérard0 个研究点目标入组 77 人开始时间: 2019年3月7日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•I1. Age = 18 years.
•I2. Histologically proven mRCC.
•I3. Brain metastases not requiring corticosteroids at dose > 40 mg/day.
•I4. At least 1 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, 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.
•...See the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 39

•E1. Any local previous treatment of current brain metastases.
•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).
•E10. Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient unsuited to study participation.
•...See the protocol

发起方

Centre Léon Bérard