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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01711268




Registration number
NCT01711268
Ethics application status
Date submitted
2/08/2012
Date registered
22/10/2012
Date last updated
15/05/2014

Titles & IDs
Public title
Sunitinib Drug Levels and Outcomes in Kidney Cancer
Scientific title
Correlating Renal Cell Cancer Treatment Efficacy With Sunitinib Therapeutic Levels and Outcomes
Secondary ID [1] 0 0
HGWH008
Universal Trial Number (UTN)
Trial acronym
CRESTO
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
Kidney

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to treatment failure (time on sunitinib treatment) - This duration extends from the date the patient starts sunitinib until the date sunitinib is abandoned. The group with sunitinib concentration below the population median are expected to have a median Time to Treatment Failure (TTF) of approximately 8 months, compared with 14 months in those with sunitinib concentration above the population median.
Timepoint [1] 0 0
Sunitinib duration (median)
Secondary outcome [1] 0 0
Toxicity - Pre-specified toxicities (BP, fatigue, diarrhoea, stomatitis, hand-foot syndrome) will be graded every 6 weeks
Timepoint [1] 0 0
Every 6 weeks
Secondary outcome [2] 0 0
Overall survival - Measured from the date of starting sunitinib treatment to the date of death from any cause
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Progression-free survival - Progression as determined by the clinician according to RECIST 1.1 definitions
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Time to second line therapy - Date of starting sunitinib treatment to the date further systemic therapy is started
Timepoint [4] 0 0
2 years

Eligibility
Key inclusion criteria
- Metastatic renal cell cancer treated with single agent sunitinib

- No known primary liver disease and no other severe or uncontrolled concurrent medical
conditions

- Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who are unable to sign informed consent

- Patients unable to give blood

- Patients who are pregnant, nursing or not using an effective contraception method

- Patients who had bone-marrow-transplantation prior to sunitinib treatment

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Crown Princess Mary Cancer Centre, Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is
50mg, but many patients require a dose decrease due to side-effects. Drug levels of sunitinib
vary approximately 10-fold between patients.

This study will measure blood levels of sunitinib and its metabolite, and correlate these
with side-effects and the response to the treatment. The study aims to establish whether
blood levels change with time, and see how useful blood levels are for monitoring patients
treated with sunitinib.
Trial website
https://clinicaltrials.gov/show/NCT01711268
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Howard Gurney, MBBS, FRACP
Address 0 0
Crown Princess Mary Cancer Centre, Westmead
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Howard Gurney, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61298455200
Fax 0 0
Email 0 0
howard.gurney@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01711268