Metastatic Renal Cell Carcinoma Clinical Trial
— CABRAMETOfficial title:
CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases
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).
Status | Recruiting |
Enrollment | 77 |
Est. completion date | December 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Institut de Cancérologie de l'Ouest-Site Paul Papin | Angers | |
France | CHU Besancon | Besançon | |
France | CHU Bordeaux | Bordeaux | |
France | Centre Jean Perrin | Clermont-Ferrand | |
France | Centre Leon Berard | Lyon | |
France | Institut de Cancérologie de la Lorraine | Nancy | |
France | Hopital Européen Georges Pompidou | Paris | |
France | Institut de Cancérologie de l'Ouest-site René Gauducheau | Saint-Herblain | |
France | ICANS | Strasbourg | |
France | Hopital Foch | Suresnes | |
France | IUCT-Institut Claudius Regaud | Toulouse | |
France | Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The non progression rate in brain metastases at 3 months | Tumor assessment in brain will be performed by cerebral MRI at baseline, 1.5 months and 3 months. These cerebral MRI will be reviewed by central review according to the RANO-BM criteria. | At 3 months for each patient | |
Secondary | Incidence of adverse events | Assessed using the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE) v5 grading scale, specific registration of neurological event during study duration. | Up to 54 months | |
Secondary | Best response in brain metastases | Evaluated according to RANDO-BM criteria. | Up to follow-up visit month 18 for each patient | |
Secondary | Duration of response in brain | From the date of inclusion to the date of first documented disease progression. | Up to 18 months for each patient | |
Secondary | Progression-free survival | Measured from the date of inclusion to the date of first documented disease progression or death from any cause. | Up to 18 months for each patient | |
Secondary | Overall survival | Measured from the date of inclusion to the date of death from any cause. | Up to 54 months |
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