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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700568
Recruitment Status : Unknown
Verified October 2017 by Kidney Cancer Research Bureau.
Recruitment status was:  Recruiting
First Posted : March 7, 2016
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Clear Cell Renal Cell Carcinoma Drug: axitinib Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018


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 Name: Inlyta




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 24 months ]
  2. Overall survival [ Time Frame: 24 months ]
  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700568


Contacts
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Contact: Ilya Tsimafeyeu, MD +79265646581 office@kidneytumor.org

Locations
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Russian Federation
Demchenkova Marina Viktorovna Recruiting
Irkutsk, Russian Federation
Semenov Andrey Vladimirovich Recruiting
Ivanovo, Russian Federation
Mikhailova Nadezhda Vasilievna Recruiting
Kazan, Russian Federation
Eskerov Kurban Abdulmutalibovich Active, not recruiting
Kirov, Russian Federation
Zukov Ruslan Aleksandrovich Recruiting
Krasnoyarsk, Russian Federation
Ovchinnikova Elena Georgievna Recruiting
Nizhny Novgorod, Russian Federation
Guseva Irina Vasilievna Recruiting
Penza, Russian Federation
Vladimirova Lyubov Yur'evna Active, not recruiting
Rostov-on-Don, Russian Federation
Zolotoreva Tatiana Gennadievna Recruiting
Samara, Russian Federation
Katkov Alexey Aleksandrovich Active, not recruiting
Saratov, Russian Federation
Ivannikov Andrey Andreyevich Recruiting
Tambov, Russian Federation
Usynin Evgeny Anatolievich Recruiting
Tomsk, Russian Federation
Evstegneyeva Irina Vladimirovna Recruiting
Tver, Russian Federation
Khmelevsky Andrey Anatolievich Recruiting
Ufa, Russian Federation
Gurina Ludmila Ivanovna Active, not recruiting
Vladivostok, Russian Federation
Sponsors and Collaborators
Kidney Cancer Research Bureau
Investigators
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Study Director: Ilya Tsimafeyeu, MD Kidney Cancer Research Bureau

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Responsible Party: Kidney Cancer Research Bureau
ClinicalTrials.gov Identifier: NCT02700568     History of Changes
Other Study ID Numbers: FAVORAX-1
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Axitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action