Clinical trial NCT02700568: Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
Official title: Evaluation of the Safety and Efficacy of Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Clear Cell Renal Cell Carcinoma
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Principle Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 10 months
Secondary outcomes:
measure: Objective response rate
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Rate of treatment-related serious adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: Demchenkova Marina Viktorovna
city: Ivanovo
country: Russian Federation
facility: Semenov Andrey Vladimirovich
city: Kazan
country: Russian Federation
facility: Mikhailova Nadezhda Vasilievna
city: Kirov
country: Russian Federation
facility: Eskerov Kurban Abdulmutalibovich
city: Krasnoyarsk
country: Russian Federation
facility: Zukov Ruslan Aleksandrovich
city: Nizhny Novgorod
country: Russian Federation
facility: Ovchinnikova Elena Georgievna
city: Penza
country: Russian Federation
facility: Guseva Irina Vasilievna
city: Rostov-on-Don
country: Russian Federation
facility: Vladimirova Lyubov Yur'evna
city: Samara
country: Russian Federation
facility: Zolotoreva Tatiana Gennadievna
city: Saratov
country: Russian Federation
facility: Katkov Alexey Aleksandrovich
city: Tambov
country: Russian Federation
facility: Ivannikov Andrey Andreyevich
city: Tomsk
country: Russian Federation
facility: Usynin Evgeny Anatolievich
city: Tver
country: Russian Federation
facility: Evstegneyeva Irina Vladimirovna
city: Ufa
country: Russian Federation
facility: Khmelevsky Andrey Anatolievich
city: Vladivostok
country: Russian Federation
facility: Gurina Ludmila Ivanovna
Study officials:
affiliation: Kidney Cancer Research Bureau
name: Ilya Tsimafeyeu, MD
role: STUDY_DIRECTOR
References: