Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

NCT ID: NCT02700568

Last Updated: 2019-10-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Carcinoma, Renal Cell Clear Cell Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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axitinib

Patients will receive axitinib.

Group Type EXPERIMENTAL

axitinib

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Inlyta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kidney Cancer Research Bureau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Semenov Andrey Vladimirovich

Ivanovo, , Russia

Site Status

Mikhailova Nadezhda Vasilievna

Kazan', , Russia

Site Status

Eskerov Kurban Abdulmutalibovich

Kirov, , Russia

Site Status

Zukov Ruslan Aleksandrovich

Krasnoyarsk, , Russia

Site Status

Ovchinnikova Elena Georgievna

Nizhny Novgorod, , Russia

Site Status

Guseva Irina Vasilievna

Penza, , Russia

Site Status

Vladimirova Lyubov Yur'evna

Rostov-on-Don, , Russia

Site Status

Zolotoreva Tatiana Gennadievna

Samara, , Russia

Site Status

Katkov Alexey Aleksandrovich

Saratov, , Russia

Site Status

Ivannikov Andrey Andreyevich

Tambov, , Russia

Site Status

Usynin Evgeny Anatolievich

Tomsk, , Russia

Site Status

Evstegneyeva Irina Vladimirovna

Tver', , Russia

Site Status

Khmelevsky Andrey Anatolievich

Ufa, , Russia

Site Status

Gurina Ludmila Ivanovna

Vladivostok, , Russia

Site Status

Countries

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Russia

Other Identifiers

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FAVORAX-1

Identifier Type: -

Identifier Source: org_study_id

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