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A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
Bu çalışma, metastatik renal hücreli karsinomu (metastatic renal cell carcinoma, böbrek kanseri) olan hastalarda Cabozantinib (XL184) ilacını Everolimus (Afinitor) ile karşılaştırmıştır. Araştırmaya, berrak hücreli bileşeni bulunan böbrek kanseri tanısı almış ve daha önce en az bir VEGFR hedefli tedavi görmüş hastalar dahil edilmiştir. Çalışma Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Select Inclusion Criteria: 1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component. 2. Measurable disease as determined by the investigator. 3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib). 4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. 5. Adequate organ and marrow function. 6. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment. 7. Female subjects of childbearing potential must not be pregnant at screening. Select Exclusion Criteria: 1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib. 2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization. 3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization. 4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. 5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization. 6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors. 7. Chronic treatment with corticosteroids or other immunosuppressive agents. 8. Serious illness other than cancer. 9. Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization. 10. Pregnant or lactating females. 11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.