Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Timepoint [1] 0 0
Sunitinib duration (median)
Secondary outcome [1] 0 0
Toxicity
Timepoint [1] 0 0
Every 6 weeks
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Progression-free survival
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Time to second line therapy
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
Sex
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2014
Actual
Sample size
Target
35
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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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