Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
- Conditions
- Carcinoma, Renal CellClear Cell Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT02700568
- Lead Sponsor
- Kidney Cancer Research Bureau
- Brief Summary
Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.
- Detailed Description
Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor-α, and c-kit. The trial of comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS) was an international randomized Phase III study designed for registration purposes. This trial randomized 723 metastatic renal cell carcinoma patients with any prognostic features to axitinib or sorafenib in the second-line setting and demonstrated significant clinical benefit of axitinib.
Aim of present FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Histologic confirmation of Renal cell carcinoma with a clear cell component
- Patients must have measurable disease
- Previous treatment with sunitinib or pazopanib
- Favorable prognosis according to IMDC criteria
- Must have available tumor tissue for submission
- Subjects must also meet various laboratory parameters for inclusion
- Patients must give written informed consent prior to initiation of therapy
- Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events
- Patients who have history of uncompensated diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description axitinib axitinib Patients will receive axitinib.
- Primary Outcome Measures
Name Time Method Progression-free survival 10 months
- Secondary Outcome Measures
Name Time Method Objective response rate 24 months Overall survival 24 months Rate of treatment-related serious adverse events 24 months Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0
Trial Locations
- Locations (15)
Usynin Evgeny Anatolievich
🇷🇺Tomsk, Russian Federation
Mikhailova Nadezhda Vasilievna
🇷🇺Kazan, Russian Federation
Ivannikov Andrey Andreyevich
🇷🇺Tambov, Russian Federation
Evstegneyeva Irina Vladimirovna
🇷🇺Tver, Russian Federation
Gurina Ludmila Ivanovna
🇷🇺Vladivostok, Russian Federation
Demchenkova Marina Viktorovna
🇷🇺Irkutsk, Russian Federation
Semenov Andrey Vladimirovich
🇷🇺Ivanovo, Russian Federation
Eskerov Kurban Abdulmutalibovich
🇷🇺Kirov, Russian Federation
Zukov Ruslan Aleksandrovich
🇷🇺Krasnoyarsk, Russian Federation
Ovchinnikova Elena Georgievna
🇷🇺Nizhny Novgorod, Russian Federation
Vladimirova Lyubov Yur'evna
🇷🇺Rostov-on-Don, Russian Federation
Guseva Irina Vasilievna
🇷🇺Penza, Russian Federation
Zolotoreva Tatiana Gennadievna
🇷🇺Samara, Russian Federation
Katkov Alexey Aleksandrovich
🇷🇺Saratov, Russian Federation
Khmelevsky Andrey Anatolievich
🇷🇺Ufa, Russian Federation