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DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12610000897066
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
21/10/2010
Date last updated
29/06/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The use of non invasive methods to predict drug handling and toxicity of Sunitinib
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Scientific title
The utility of genomics and functional imaging to predict Sunitinib pharmacokinetics and pharmacodynamics: The PREDICT SU Study
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Secondary ID [1]
252880
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PMCC Protocol No 10/56
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Universal Trial Number (UTN)
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Trial acronym
The PREDICT SU Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic renal cell carcinoma (RCC)
258411
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Metastatic Gastrointestinal Stromal Tumuor (GIST)
258412
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Condition category
Condition code
Cancer
258577
258577
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0
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Kidney
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Cancer
258578
258578
0
0
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Other cancer types
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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
Standard treatment
Toxicity, response, Pharmacogenomics and Liver Imaging will be observed over 2 cycles of Sunitinib treatment (3 months).
Total duration of the study 4 years
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Intervention code [1]
257407
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Not applicable
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Correlate MIBI hepatic functional imaging with the Pharmacokinetics and Toxicity of Sunitinib.
Associations will be assessed to examine the strength and direction of the linear relationship between HFI with PK and toxicity parameters. The Pearson correlation coefficient (for normally distributed variables) or nonparametric Spearman rank correlation (for any non-normally distributed variables) will be calculated with the correlation (r2) and p-value reported. Linear regression models to predict PK parameters from HFI parameters will be fitted to estimate the relationship between pairs of parameters identified as having a significant correlation coefficient. Logistic regression will be used to assess whether HFI parameters can predict presence or absence of toxicity.
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Assessment method [1]
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Timepoint [1]
259431
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Assess response at the 3 months time point then PFS and OS retrospectively
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Primary outcome [2]
259432
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Correlate the combined Pharmacogenomics of excretory/metabolic and pharmacodynamic enzymes with Sunitinib pharmacokinetics, toxicity and response.
SNP genotypes will be assessed for deviations from Hardy-Weinberg equilibrium. Fisher's exact test or Pearson's chi-square test will be used, as appropriate, to assess the association between SNP genotypes with toxicity and objective response in 2 degree of freedom tests. Linear and logistic regressions will be used to assess the relationship between the number of minor alleles at each SNP with pharmacokinetic, toxicity and response parameters, as appropriate, in 1 degree of freedom tests.
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Assessment method [2]
259432
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Timepoint [2]
259432
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4th year of the project
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Primary outcome [3]
259433
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Develop and validate a novel non-invasive population dosing model based on MIBI imaging and pharmacogenomic factors, for the safe and effective dosing of Sunitinib.
The genotypic and imaging parameters which showed some evidence of an association with toxicity or response will be tested for inclusion as covariates in logistic regression models for the prediction of toxicity and tumour response. Patient baseline demographics and other measured variables will also be considered. The improvement in model fit, as assessed by chi-squared statistics will determine whether a variable is included in the analysis
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Assessment method [3]
259433
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Timepoint [3]
259433
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4th year of the project
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Secondary outcome [1]
265980
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Nil
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Assessment method [1]
265980
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Timepoint [1]
265980
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Nil
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Eligibility
Key inclusion criteria
Cytologically/histologically proven advanced or metastatic renal cell carcinoma (RCC) or gastrointestinal stromal tumour (GIST) after failure of imatinib treatment due to resistance or intolerance with one or more measurable or evaluable lesions, adequate hepatic, bone marrow and renal function, Eastern Cooperative Oncology Group (ECOG) 2 or less life expectancy greater than 12 weeks, written informed consent for the study and its associated procedures. Patients that are to start Sunitinib therapy for the approved indications.
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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
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol or compromises the patient's ability to give informed consent. Conditions that compromise oral absorption, any unresolved toxicity greater than NCI-CTC Grade 2 from previous anti-cancer therapy, co-administration of potent Cytochrome 3A4/5 inducers (phenytoin, carbamazepine, rifampicin, phenobarbitone, St John’s wort) 12 days prior to dosing, co-administration of potent Cytochrome 3A4/5 inhibitors (ketoconazole, erythromycin, clarithromycin, itraconazole, HIV antivirals and grapefruit juice) within 7 days of dosing, uncontrolled hypertension (BP >150/100mmHg despite optimal medical therapy), active bleeding disorders within the last 3 months, NYHA Grade III/IV cardiac problems (e.g. congestive heart failure, or myocardial infarction or active myocardial ischemia within 6 months of study), history of cerebrovascular accident including TIA or pulmonary embolism within 12 months, known diagnosis of human immunodeficiency virus (HIV) infection, active liver disease (e.g., chronic active hepatitis, cirrhosis), major surgery within 21 days prior to commencing study drugs
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/11/2010
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Actual
2/05/2012
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Date of last participant enrolment
Anticipated
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Actual
24/10/2014
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Date of last data collection
Anticipated
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Actual
4/08/2016
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Sample size
Target
70
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment postcode(s) [1]
3317
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3002
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Recruitment postcode(s) [2]
3318
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3050
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Recruitment postcode(s) [3]
3319
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3084
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Recruitment postcode(s) [4]
3320
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3011
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Recruitment postcode(s) [5]
3321
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3128
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Recruitment postcode(s) [6]
3322
0
3199
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Recruitment postcode(s) [7]
3323
0
5042
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Recruitment postcode(s) [8]
3324
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5011
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Recruitment postcode(s) [9]
3325
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2065
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Recruitment postcode(s) [10]
3326
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2217
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Recruitment postcode(s) [11]
3327
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2139
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Funding & Sponsors
Funding source category [1]
257845
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Government body
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Name [1]
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National Health and Medical Research Council of Australia
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Address [1]
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
257845
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Australia
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Primary sponsor type
Hospital
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Name
Peter MacCallum Cancer Centre
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Address
St Andrew’s Place, East Melbourne, VIC, 3002
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Country
Australia
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Secondary sponsor category [1]
257052
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None
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Name [1]
257052
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Address [1]
257052
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Country [1]
257052
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Other collaborator category [1]
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Individual
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Name [1]
251585
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Assoc Prof. Michael Jefford
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Address [1]
251585
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country [1]
251585
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Australia
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Other collaborator category [2]
251586
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Individual
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Name [2]
251586
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Prof J Zalcberg
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Address [2]
251586
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country [2]
251586
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Australia
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Other collaborator category [3]
251587
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Individual
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Name [3]
251587
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Dr C Cullinane
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Address [3]
251587
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Translational Research Laboratory
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country [3]
251587
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Australia
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Other collaborator category [4]
251588
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Individual
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Name [4]
251588
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Assoc Prof Ian Campbell
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Address [4]
251588
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Cancer Genetics
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country [4]
251588
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Australia
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Other collaborator category [5]
251589
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Individual
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Name [5]
251589
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Assoc Prof. N Tebbutt
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Address [5]
251589
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Dept of Medical Oncology
Austin Hospital
Studley Road, Heidelberg Heights, VIC, 3084
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Country [5]
251589
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Australia
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Other collaborator category [6]
251590
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Individual
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Name [6]
251590
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Prof A Scott
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Address [6]
251590
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Dept of Nuclear Medicine and Ludwig Institute
Studley Road, Heidelberg Heights, VIC, 3084
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Country [6]
251590
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Australia
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Other collaborator category [7]
251591
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Individual
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Name [7]
251591
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Assoc Prof L Lipton
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Address [7]
251591
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Medical Oncology and Clinical Haematology Unit
Western Hospital
Gordon Street, Footscray, VIC, 3011
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Country [7]
251591
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Australia
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Other collaborator category [8]
251592
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Individual
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Name [8]
251592
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Dr J Desai
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Address [8]
251592
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Dept of Medical Oncology ,
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country [8]
251592
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Australia
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Other collaborator category [9]
251593
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Individual
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Name [9]
251593
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Dr Vinod Ganju
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Address [9]
251593
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Department of Medical Oncology
Peninsula Oncology Centre
24-28 Frankston-Flinders Road, Frankston, VIC, 3199
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Country [9]
251593
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Australia
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Other collaborator category [10]
251594
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Individual
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Name [10]
251594
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Dr Phillip Parente
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Address [10]
251594
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Department of Medical Oncology
Box Hill Hospital
Nelson Road, Box Hill, VIC, 3128
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Country [10]
251594
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Australia
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Other collaborator category [11]
251595
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Individual
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Name [11]
251595
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Assco Prof Joe McKendrick
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Address [11]
251595
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Department of Medical Oncology
Box Hill Hospital
Nelson Road, Box Hill, VIC, 3128
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Country [11]
251595
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Australia
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Other collaborator category [12]
251596
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Individual
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Name [12]
251596
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Assoc Prof Sue-Anne McLachlan
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Address [12]
251596
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St Vincent's Hospital
41 Victoria Parade, Fitzroy, VIC, 3065
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Country [12]
251596
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Australia
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Other collaborator category [13]
251597
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Individual
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Name [13]
251597
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Prof S Clarke
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Address [13]
251597
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Dept of Medicine and Medical Oncology
Concord Hospital
Hospital Road, Concord, NSW, 2139
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Country [13]
251597
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Australia
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Other collaborator category [14]
251598
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Individual
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Name [14]
251598
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Assoc Prof L Hovarth
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Address [14]
251598
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Dept of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road, Camperdown, NSW, 2050
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Country [14]
251598
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Australia
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Other collaborator category [15]
251599
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Individual
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Name [15]
251599
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Dr W Liauw
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Address [15]
251599
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Dept of Medical Oncology
St Georges Hospital
Gray Street, Kogarah, NSW, 2217
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Country [15]
251599
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Australia
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Other collaborator category [16]
251600
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Individual
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Name [16]
251600
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Assoc Prof M Links
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Address [16]
251600
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Dept of Medical Oncology
Royal North Shore Hospital
Pacific Highway, St Leonards, NSW, 2065
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Country [16]
251600
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Australia
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Other collaborator category [17]
251601
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Individual
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Name [17]
251601
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Dr N Pavlakis
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Address [17]
251601
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Dept Medical Oncology
Queen Elizabeth Hospital
Woodville Road, Woodville, SA, 5011
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Country [17]
251601
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Australia
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Other collaborator category [18]
251602
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Individual
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Name [18]
251602
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Assoc Prof T Price
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Address [18]
251602
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Dept Medical Oncology
Flinders Medical Centre
Flinders Drive, Bedford Park, SA, 5042
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Country [18]
251602
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Australia
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Other collaborator category [19]
251603
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Individual
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Name [19]
251603
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Dr C Karapetis
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Address [19]
251603
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Dept of Medical Oncology
Flinders Medical Centre
Flinders Drive, Bedford Park, SA, 5042
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Country [19]
251603
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
259881
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Peter MacCallum Cancer Centre Ethics Committee
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Ethics committee address [1]
259881
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Level 4, 10 St Andrews Place
East Melbourne, Victoria, 3002
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Ethics committee country [1]
259881
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Australia
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Date submitted for ethics approval [1]
259881
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07/07/2010
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Approval date [1]
259881
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03/09/2010
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Ethics approval number [1]
259881
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PMCC Protocol No: 10/56
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Summary
Brief summary
Suntinib is a drug with variable PK and toxicity profile that impacts upon its clinical use. This study will be targeted to patients receiving Sunitinib for the treatment of advanced renal cell cancer or GIST. Patients will have functional hepatic imaging and blood taken for pharmacogenomic studies of drug handling and drug target enzyme genes. During treatment patients will be monitored for response and toxicity and have bloods taken for steady state PK. We will then try to correlate PK, toxicity and response with liver imaging and genomic parameters in an attempt to develop doing nomograms.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31779
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A/Prof Michael Michael
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Address
31779
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Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Australia
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Country
31779
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Australia
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Phone
31779
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+61 3 8559 7860
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Fax
31779
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Email
31779
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[email protected]
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Contact person for public queries
Name
15026
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A/Prof Assoc Prof M Michael
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Address
15026
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country
15026
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Australia
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Phone
15026
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+61 3 96561159
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Fax
15026
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+61 3 96561408
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Email
15026
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[email protected]
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Contact person for scientific queries
Name
5954
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A/Prof Assoc Prof M Michael
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Address
5954
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country
5954
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Australia
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Phone
5954
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+61 3 96561159
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Fax
5954
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+61 3 96561408
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Email
5954
0
[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Pharmacogenomics and functional imaging to predict irinotecan pharmacokinetics and pharmacodynamics: the predict IR study.
2021
https://dx.doi.org/10.1007/s00280-021-04264-8
Embase
Evaluation of pharmacogenomics and hepatic nuclear imaging-related covariates by population pharmacokinetic models of irinotecan and its metabolites.
2022
https://dx.doi.org/10.1007/s00228-021-03206-w
N.B. These documents automatically identified may not have been verified by the study sponsor.
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