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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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Scientific title
Correlating Renal Cell Cancer Treatment Efficacy With Sunitinib Therapeutic Levels and Outcomes
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Secondary ID [1]
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HGWH008
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Universal Trial Number (UTN)
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Trial acronym
CRESTO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Kidney
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to treatment failure (time on sunitinib treatment)
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Assessment method [1]
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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.
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Timepoint [1]
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Sunitinib duration (median)
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Secondary outcome [1]
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Toxicity
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Assessment method [1]
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Pre-specified toxicities (BP, fatigue, diarrhoea, stomatitis, hand-foot syndrome) will be graded every 6 weeks
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Timepoint [1]
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Every 6 weeks
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Secondary outcome [2]
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Overall survival
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Assessment method [2]
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Measured from the date of starting sunitinib treatment to the date of death from any cause
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Progression-free survival
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Assessment method [3]
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Progression as determined by the clinician according to RECIST 1.1 definitions
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Time to second line therapy
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Assessment method [4]
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Date of starting sunitinib treatment to the date further systemic therapy is started
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Timepoint [4]
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2 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2014
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Actual
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Sample size
Target
35
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Crown Princess Mary Cancer Centre, Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Western Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01711268
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Howard Gurney, MBBS, FRACP
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Address
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Crown Princess Mary Cancer Centre, Westmead
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Howard Gurney, MBBS, FRACP
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Address
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Country
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Phone
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+61298455200
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01711268
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