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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00678392




Registration number
NCT00678392
Ethics application status
Date submitted
12/05/2008
Date registered
15/05/2008

Titles & IDs
Public title
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Scientific title
AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
Secondary ID [1] 0 0
AXIS TRIAL
Secondary ID [2] 0 0
A4061032
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Axitinib (AG-013736)
Treatment: Drugs - Sorafenib

Experimental: Axitinib -

Active comparator: Sorafenib -


Treatment: Drugs: Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg twice daily \[BID\] with continuous dosing

Treatment: Drugs: Sorafenib
sorafenib will be given at a dose of 400 mg twice daily \[BID\] with continuous dosing
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [4] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [4] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [5] 0 0
Percentage of Participants With Adverse Events (AEs) by Severity
Timepoint [5] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [6] 0 0
Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [7] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Timepoint [7] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Timepoint [8] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [9] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Timepoint [9] 0 0
From initiation of treatment up to follow-up period (up to 3 years)
Secondary outcome [10] 0 0
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Timepoint [10] 0 0
Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Secondary outcome [11] 0 0
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Timepoint [11] 0 0
Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Secondary outcome [12] 0 0
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Timepoint [12] 0 0
Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Secondary outcome [13] 0 0
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Timepoint [13] 0 0
Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
* Evidence of measurable disease
* Must have failed one prior systemic first-line regimen for metastatic renal cell cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
* Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/02/2016
Sample size
Target
Accrual to date
Final
723
Recruitment in Australia
Recruitment state(s)
ACT,SA,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital, Medical Oncology - Garran
Recruitment hospital [2] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [3] 0 0
Ballarat Oncology & Haematology Services - Ballarat
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [5] 0 0
Heidelberg Repatriation Hospital, Austin Health - Heidelberg West
Recruitment hospital [6] 0 0
Austin Hospital, Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
3350 - Ballarat
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
Country [20] 0 0
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Austria
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Wien
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SP
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Canada
State/province [29] 0 0
Alberta
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State/province [30] 0 0
British Columbia
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State/province [31] 0 0
New Brunswick
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Canada
State/province [32] 0 0
Newfoundland and Labrador
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Canada
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Ontario
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China
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Chaoyang District
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Jiangsu
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P.R.
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Shaanxi
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Guangzhou
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China
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Tianjin
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France
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Paris Cedex 15
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France
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Rennes
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France
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St Herblain Cedex
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France
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Tours Cedex 1
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France
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Vandoeuvre les Nancy
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France
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Villejuif Cedex
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Essen
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Germany
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Hannover
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Oldenburg
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Greece
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Attiki
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Greece
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Macedonia
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India
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Haryana
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India
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Kerala
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India
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Rajasthan
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Ireland
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Dublin 24
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Arezzo
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Aviano (PN)
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Italy
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Brescia
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Cremona
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Genova
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Milano
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Napoli
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Padova
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Pavia
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Italy
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Roma
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Rozzano (MI)
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Hokkaido
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Ibaraki
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Chiba
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Fukuoka
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Kumamoto
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Tokushima
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Yamagata
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Gyeonggi-do
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Busan
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Gdansk
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Wroclaw
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Russian Federation
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Zilina
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Barcelona
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Navarra
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Malaga
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Sevilla
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Spain
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Zaragoza
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Sweden
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Linkoping
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Sweden
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Umea
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Sweden
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Vaxjo
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Taiwan
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Kaohsiung Hsien
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
State/province [116] 0 0
England
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Middlesex
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Bebington, Wirral
Country [119] 0 0
United Kingdom
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Birmingham
Country [120] 0 0
United Kingdom
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Bournemouth
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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London
Country [125] 0 0
United Kingdom
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Oxford
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00678392