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

Primary Purpose

Carcinoma, Renal Cell, Clear Cell Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
axitinib
Sponsored by
Kidney Cancer Research Bureau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Demchenkova Marina Viktorovna
  • Semenov Andrey Vladimirovich
  • Mikhailova Nadezhda Vasilievna
  • Eskerov Kurban Abdulmutalibovich
  • Zukov Ruslan Aleksandrovich
  • Ovchinnikova Elena Georgievna
  • Guseva Irina Vasilievna
  • Vladimirova Lyubov Yur'evna
  • Zolotoreva Tatiana Gennadievna
  • Katkov Alexey Aleksandrovich
  • Ivannikov Andrey Andreyevich
  • Usynin Evgeny Anatolievich
  • Evstegneyeva Irina Vladimirovna
  • Khmelevsky Andrey Anatolievich
  • Gurina Ludmila Ivanovna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

axitinib

Arm Description

Patients will receive axitinib.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Objective response rate
Overall survival
Rate of treatment-related serious adverse events
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0

Full Information

First Posted
January 18, 2016
Last Updated
October 18, 2019
Sponsor
Kidney Cancer Research Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT02700568
Brief Title
Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
Acronym
FavorAx
Official Title
Evaluation of the Safety and Efficacy of Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kidney Cancer Research Bureau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Clear Cell Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
axitinib
Arm Type
Experimental
Arm Description
Patients will receive axitinib.
Intervention Type
Drug
Intervention Name(s)
axitinib
Other Intervention Name(s)
Inlyta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
24 months
Title
Overall survival
Time Frame
24 months
Title
Rate of treatment-related serious adverse events
Description
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Tsimafeyeu, MD
Organizational Affiliation
Kidney Cancer Research Bureau
Official's Role
Study Director
Facility Information:
Facility Name
Demchenkova Marina Viktorovna
City
Irkutsk
Country
Russian Federation
Facility Name
Semenov Andrey Vladimirovich
City
Ivanovo
Country
Russian Federation
Facility Name
Mikhailova Nadezhda Vasilievna
City
Kazan
Country
Russian Federation
Facility Name
Eskerov Kurban Abdulmutalibovich
City
Kirov
Country
Russian Federation
Facility Name
Zukov Ruslan Aleksandrovich
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Ovchinnikova Elena Georgievna
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Guseva Irina Vasilievna
City
Penza
Country
Russian Federation
Facility Name
Vladimirova Lyubov Yur'evna
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Zolotoreva Tatiana Gennadievna
City
Samara
Country
Russian Federation
Facility Name
Katkov Alexey Aleksandrovich
City
Saratov
Country
Russian Federation
Facility Name
Ivannikov Andrey Andreyevich
City
Tambov
Country
Russian Federation
Facility Name
Usynin Evgeny Anatolievich
City
Tomsk
Country
Russian Federation
Facility Name
Evstegneyeva Irina Vladimirovna
City
Tver
Country
Russian Federation
Facility Name
Khmelevsky Andrey Anatolievich
City
Ufa
Country
Russian Federation
Facility Name
Gurina Ludmila Ivanovna
City
Vladivostok
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

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