Evaluation of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases

Launched by CENTRE LEON BERARD · May 29, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called cabozantinib in patients who have metastatic renal cell carcinoma (mRCC) that has spread to the brain. The main goal is to see how well this treatment works and to understand its safety for patients with brain metastases from this type of cancer. The study is currently recruiting participants who are at least 18 years old, have a confirmed diagnosis of mRCC, and have specific brain lesions that meet certain criteria.

To be eligible, patients should not have received cabozantinib before and must have good overall health, meaning they can perform daily activities with minimal assistance. Participants will receive the treatment and will need to attend regular visits for monitoring and tests throughout the study. It’s important to know that those with certain medical conditions or who are pregnant or breastfeeding cannot join the trial. This study aims to provide valuable information that could help improve treatment options for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• 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. 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.
• • 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 of cabozantinib.
• • E16. Patient requiring tutorship or curatorship.