Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors (FavorAx)

October 18, 2019 updated by: Kidney Cancer Research Bureau

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: axitinib
Patients will receive axitinib.
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.
Other Names:
  • Inlyta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 10 months
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 24 months
24 months
Objective response rate
Time Frame: 24 months
24 months
Rate of treatment-related serious adverse events
Time Frame: 24 months
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kidney Cancer Research Bureau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (ESTIMATE)

March 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAVORAX-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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