Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
NCT ID: NCT02700568
Last Updated: 2019-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2016-01-31
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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axitinib
Patients will receive axitinib.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Kidney Cancer Research Bureau
OTHER
Responsible Party
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Principal Investigators
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Ilya Tsimafeyeu, MD
Role: STUDY_DIRECTOR
Kidney Cancer Research Bureau
Locations
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Demchenkova Marina Viktorovna
Irkutsk, , Russia
Semenov Andrey Vladimirovich
Ivanovo, , Russia
Mikhailova Nadezhda Vasilievna
Kazan', , Russia
Eskerov Kurban Abdulmutalibovich
Kirov, , Russia
Zukov Ruslan Aleksandrovich
Krasnoyarsk, , Russia
Ovchinnikova Elena Georgievna
Nizhny Novgorod, , Russia
Guseva Irina Vasilievna
Penza, , Russia
Vladimirova Lyubov Yur'evna
Rostov-on-Don, , Russia
Zolotoreva Tatiana Gennadievna
Samara, , Russia
Katkov Alexey Aleksandrovich
Saratov, , Russia
Ivannikov Andrey Andreyevich
Tambov, , Russia
Usynin Evgeny Anatolievich
Tomsk, , Russia
Evstegneyeva Irina Vladimirovna
Tver', , Russia
Khmelevsky Andrey Anatolievich
Ufa, , Russia
Gurina Ludmila Ivanovna
Vladivostok, , Russia
Countries
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Other Identifiers
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FAVORAX-1
Identifier Type: -
Identifier Source: org_study_id
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