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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01473043




Registration number
NCT01473043
Ethics application status
Date submitted
14/11/2011
Date registered
17/11/2011
Date last updated
30/05/2014

Titles & IDs
Public title
Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment
Scientific title
Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy
Secondary ID [1] 0 0
A4061061
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Axitinib

Treatment: Drugs: Axitinib
5mg twice daily \[BD\] daily dosing until progression or prohibitive toxicity Dose titration by 2 levels upwards (7mg and 10mg) and downwards (3mg and 2mg) allowed per protocol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Metastatic renal cell carcinoma with a component of clear cell subtype.
* Prior first line systemic therapy
* At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors [RECIST 1.1].
* Adequate hematology, liver and kidney functions
* Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1.
* Life expectancy of =12 weeks.
* Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.)
* Negative pregnancy test
* Adequate recovery time from prior systemic therapy, surgery or radiation
* Willing and able subjects who have signed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* More than one prior systemic therapy regimen
* Major bowel-penetrating surgery <4 weeks
* Active gastro intestinal bleed in past 3 months
* Active peptic ulcer disease in the past 6 months
* Current or anticipated use of potent CYP3A4/5 inhibitors
* Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers
* Requirement for therapeutic warfarin or high dose steroids
* Symptomatic or untreated brain metastases
* A serious uncontrolled medical disorder or active infection
* Pregnant or breastfeeding females
* History of another active malignancy
* Dementia

Study design
Purpose of the study
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
NO_LONGER_AVAILABLE
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Douglas
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Hobart
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Wendouree
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.
Trial website
https://clinicaltrials.gov/study/NCT01473043
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01473043