Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02700568
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2016-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077784', 'term': 'Axitinib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2016-01-18', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '10 months'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '24 months'}, {'measure': 'Overall survival', 'timeFrame': '24 months'}, {'measure': 'Rate of treatment-related serious adverse events', 'timeFrame': '24 months', 'description': 'Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell', 'Clear Cell Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAim 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Principle Inclusion Criteria:\n\n* Histologic confirmation of Renal cell carcinoma with a clear cell component\n* Patients must have measurable disease\n* Previous treatment with sunitinib or pazopanib\n* Favorable prognosis according to IMDC criteria\n* Must have available tumor tissue for submission\n* Subjects must also meet various laboratory parameters for inclusion\n* Patients must give written informed consent prior to initiation of therapy\n\nExclusion Criteria:\n\n* 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\n* 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.'}, 'identificationModule': {'nctId': 'NCT02700568', 'acronym': 'FavorAx', 'briefTitle': 'Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors', 'organization': {'class': 'OTHER', 'fullName': 'Kidney Cancer Research Bureau'}, 'officialTitle': 'Evaluation of the Safety and Efficacy of Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors', 'orgStudyIdInfo': {'id': 'FAVORAX-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'axitinib', 'description': 'Patients will receive axitinib.', 'interventionNames': ['Drug: axitinib']}], 'interventions': [{'name': 'axitinib', 'type': 'DRUG', 'otherNames': ['Inlyta'], '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.', 'armGroupLabels': ['axitinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Demchenkova Marina Viktorovna', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'city': 'Ivanovo', 'country': 'Russia', 'facility': 'Semenov Andrey Vladimirovich', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Mikhailova Nadezhda Vasilievna', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Kirov', 'country': 'Russia', 'facility': 'Eskerov Kurban Abdulmutalibovich', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Zukov Ruslan Aleksandrovich', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Ovchinnikova Elena Georgievna', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Penza', 'country': 'Russia', 'facility': 'Guseva Irina Vasilievna', 'geoPoint': {'lat': 53.19568, 'lon': 45.01075}}, {'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': "Vladimirova Lyubov Yur'evna", 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Zolotoreva Tatiana Gennadievna', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Saratov', 'country': 'Russia', 'facility': 'Katkov Alexey Aleksandrovich', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'city': 'Tambov', 'country': 'Russia', 'facility': 'Ivannikov Andrey Andreyevich', 'geoPoint': {'lat': 52.73632, 'lon': 41.44102}}, {'city': 'Tomsk', 'country': 'Russia', 'facility': 'Usynin Evgeny Anatolievich', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': "Tver'", 'country': 'Russia', 'facility': 'Evstegneyeva Irina Vladimirovna', 'geoPoint': {'lat': 56.85836, 'lon': 35.90057}}, {'city': 'Ufa', 'country': 'Russia', 'facility': 'Khmelevsky Andrey Anatolievich', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'city': 'Vladivostok', 'country': 'Russia', 'facility': 'Gurina Ludmila Ivanovna', 'geoPoint': {'lat': 43.10562, 'lon': 131.87353}}], 'overallOfficials': [{'name': 'Ilya Tsimafeyeu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kidney Cancer Research Bureau'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kidney Cancer Research Bureau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}