NCT02700568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

January 18, 2016

Last Update Submit

October 18, 2019

Conditions

Carcinoma, Renal CellClear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    10 months

Secondary Outcomes (3)

  • Objective response rate

    24 months

  • Overall survival

    24 months

  • Rate of treatment-related serious adverse events

    24 months

Study Arms (1)

axitinib

EXPERIMENTAL

Patients will receive axitinib.

Drug: axitinib

Interventions

axitinibDRUG

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.

Also known as: Inlyta
axitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patients must give written informed consent prior to initiation of therapy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Demchenkova Marina Viktorovna

Irkutsk, Russia

Location

Semenov Andrey Vladimirovich

Ivanovo, Russia

Location

Mikhailova Nadezhda Vasilievna

Kazan', Russia

Location

Eskerov Kurban Abdulmutalibovich

Kirov, Russia

Location

Zukov Ruslan Aleksandrovich

Krasnoyarsk, Russia

Location

Ovchinnikova Elena Georgievna

Nizhny Novgorod, Russia

Location

Guseva Irina Vasilievna

Penza, Russia

Location

Vladimirova Lyubov Yur'evna

Rostov-on-Don, Russia

Location

Zolotoreva Tatiana Gennadievna

Samara, Russia

Location

Katkov Alexey Aleksandrovich

Saratov, Russia

Location

Ivannikov Andrey Andreyevich

Tambov, Russia

Location

Usynin Evgeny Anatolievich

Tomsk, Russia

Location

Evstegneyeva Irina Vladimirovna

Tver', Russia

Location

Khmelevsky Andrey Anatolievich

Ufa, Russia

Location

Gurina Ludmila Ivanovna

Vladivostok, Russia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ilya Tsimafeyeu, MD

    Kidney Cancer Research Bureau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

March 7, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2018

Study Completion

August 1, 2018

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

RU(15)