Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

Carcinoma, Renal Cell Clinical Trial

— FavorAx  

Official title:

Evaluation of the Safety and Efficacy of Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700568
• Other study ID #: FAVORAX-1
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2019
• Source: Kidney Cancer Research Bureau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Drug:
• axitinib
Initial dose of axitinib: 5 mg orally twice a day. Maintenance dose of axitinib: Increase or decrease dose based on individual safety and tolerability. Dose range of axitinib: 2 to 10 mg twice a day.

Locations

Country	Name	City	State
Russian Federation	Demchenkova Marina Viktorovna	Irkutsk
Russian Federation	Semenov Andrey Vladimirovich	Ivanovo
Russian Federation	Mikhailova Nadezhda Vasilievna	Kazan
Russian Federation	Eskerov Kurban Abdulmutalibovich	Kirov
Russian Federation	Zukov Ruslan Aleksandrovich	Krasnoyarsk
Russian Federation	Ovchinnikova Elena Georgievna	Nizhny Novgorod
Russian Federation	Guseva Irina Vasilievna	Penza
Russian Federation	Vladimirova Lyubov Yur'evna	Rostov-on-Don
Russian Federation	Zolotoreva Tatiana Gennadievna	Samara
Russian Federation	Katkov Alexey Aleksandrovich	Saratov
Russian Federation	Ivannikov Andrey Andreyevich	Tambov
Russian Federation	Usynin Evgeny Anatolievich	Tomsk
Russian Federation	Evstegneyeva Irina Vladimirovna	Tver
Russian Federation	Khmelevsky Andrey Anatolievich	Ufa
Russian Federation	Gurina Ludmila Ivanovna	Vladivostok

Sponsors (1)

Lead Sponsor	Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		10 months
Secondary	Objective response rate		24 months
Secondary	Overall survival		24 months
Secondary	Rate of treatment-related serious adverse events	Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0	24 months