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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
Scientific title
The utility of genomics and functional imaging to predict Sunitinib pharmacokinetics and pharmacodynamics: The PREDICT SU Study
Secondary ID [1] 252880 0
PMCC Protocol No 10/56
Universal Trial Number (UTN)
Trial acronym
The PREDICT SU Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic renal cell carcinoma (RCC) 258411 0
Metastatic Gastrointestinal Stromal Tumuor (GIST) 258412 0
Condition category
Condition code
Cancer 258577 258577 0 0
Kidney
Cancer 258578 258578 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 257407 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259431 0
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.
Timepoint [1] 259431 0
Assess response at the 3 months time point then PFS and OS retrospectively
Primary outcome [2] 259432 0
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.
Timepoint [2] 259432 0
4th year of the project
Primary outcome [3] 259433 0
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
Timepoint [3] 259433 0
4th year of the project
Secondary outcome [1] 265980 0
Nil
Timepoint [1] 265980 0
Nil

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
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,QLD,SA,VIC
Recruitment postcode(s) [1] 3317 0
3002
Recruitment postcode(s) [2] 3318 0
3050
Recruitment postcode(s) [3] 3319 0
3084
Recruitment postcode(s) [4] 3320 0
3011
Recruitment postcode(s) [5] 3321 0
3128
Recruitment postcode(s) [6] 3322 0
3199
Recruitment postcode(s) [7] 3323 0
5042
Recruitment postcode(s) [8] 3324 0
5011
Recruitment postcode(s) [9] 3325 0
2065
Recruitment postcode(s) [10] 3326 0
2217
Recruitment postcode(s) [11] 3327 0
2139

Funding & Sponsors
Funding source category [1] 257845 0
Government body
Name [1] 257845 0
National Health and Medical Research Council of Australia
Address [1] 257845 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 257845 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrew’s Place, East Melbourne, VIC, 3002
Country
Australia
Secondary sponsor category [1] 257052 0
None
Name [1] 257052 0
Address [1] 257052 0
Country [1] 257052 0
Other collaborator category [1] 251585 0
Individual
Name [1] 251585 0
Assoc Prof. Michael Jefford
Address [1] 251585 0
Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
Country [1] 251585 0
Australia
Other collaborator category [2] 251586 0
Individual
Name [2] 251586 0
Prof J Zalcberg
Address [2] 251586 0
Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
Country [2] 251586 0
Australia
Other collaborator category [3] 251587 0
Individual
Name [3] 251587 0
Dr C Cullinane
Address [3] 251587 0
Translational Research Laboratory
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
Country [3] 251587 0
Australia
Other collaborator category [4] 251588 0
Individual
Name [4] 251588 0
Assoc Prof Ian Campbell
Address [4] 251588 0
Cancer Genetics
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
Country [4] 251588 0
Australia
Other collaborator category [5] 251589 0
Individual
Name [5] 251589 0
Assoc Prof. N Tebbutt
Address [5] 251589 0
Dept of Medical Oncology
Austin Hospital
Studley Road, Heidelberg Heights, VIC, 3084
Country [5] 251589 0
Australia
Other collaborator category [6] 251590 0
Individual
Name [6] 251590 0
Prof A Scott
Address [6] 251590 0
Dept of Nuclear Medicine and Ludwig Institute
Studley Road, Heidelberg Heights, VIC, 3084
Country [6] 251590 0
Australia
Other collaborator category [7] 251591 0
Individual
Name [7] 251591 0
Assoc Prof L Lipton
Address [7] 251591 0
Medical Oncology and Clinical Haematology Unit
Western Hospital
Gordon Street, Footscray, VIC, 3011
Country [7] 251591 0
Australia
Other collaborator category [8] 251592 0
Individual
Name [8] 251592 0
Dr J Desai
Address [8] 251592 0
Dept of Medical Oncology ,
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
Country [8] 251592 0
Australia
Other collaborator category [9] 251593 0
Individual
Name [9] 251593 0
Dr Vinod Ganju
Address [9] 251593 0
Department of Medical Oncology
Peninsula Oncology Centre
24-28 Frankston-Flinders Road, Frankston, VIC, 3199
Country [9] 251593 0
Australia
Other collaborator category [10] 251594 0
Individual
Name [10] 251594 0
Dr Phillip Parente
Address [10] 251594 0
Department of Medical Oncology
Box Hill Hospital
Nelson Road, Box Hill, VIC, 3128
Country [10] 251594 0
Australia
Other collaborator category [11] 251595 0
Individual
Name [11] 251595 0
Assco Prof Joe McKendrick
Address [11] 251595 0
Department of Medical Oncology
Box Hill Hospital
Nelson Road, Box Hill, VIC, 3128
Country [11] 251595 0
Australia
Other collaborator category [12] 251596 0
Individual
Name [12] 251596 0
Assoc Prof Sue-Anne McLachlan
Address [12] 251596 0
St Vincent's Hospital
41 Victoria Parade, Fitzroy, VIC, 3065
Country [12] 251596 0
Australia
Other collaborator category [13] 251597 0
Individual
Name [13] 251597 0
Prof S Clarke
Address [13] 251597 0
Dept of Medicine and Medical Oncology
Concord Hospital
Hospital Road, Concord, NSW, 2139
Country [13] 251597 0
Australia
Other collaborator category [14] 251598 0
Individual
Name [14] 251598 0
Assoc Prof L Hovarth
Address [14] 251598 0
Dept of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road, Camperdown, NSW, 2050
Country [14] 251598 0
Australia
Other collaborator category [15] 251599 0
Individual
Name [15] 251599 0
Dr W Liauw
Address [15] 251599 0
Dept of Medical Oncology
St Georges Hospital
Gray Street, Kogarah, NSW, 2217
Country [15] 251599 0
Australia
Other collaborator category [16] 251600 0
Individual
Name [16] 251600 0
Assoc Prof M Links
Address [16] 251600 0
Dept of Medical Oncology
Royal North Shore Hospital
Pacific Highway, St Leonards, NSW, 2065
Country [16] 251600 0
Australia
Other collaborator category [17] 251601 0
Individual
Name [17] 251601 0
Dr N Pavlakis
Address [17] 251601 0
Dept Medical Oncology
Queen Elizabeth Hospital
Woodville Road, Woodville, SA, 5011
Country [17] 251601 0
Australia
Other collaborator category [18] 251602 0
Individual
Name [18] 251602 0
Assoc Prof T Price
Address [18] 251602 0
Dept Medical Oncology
Flinders Medical Centre
Flinders Drive, Bedford Park, SA, 5042
Country [18] 251602 0
Australia
Other collaborator category [19] 251603 0
Individual
Name [19] 251603 0
Dr C Karapetis
Address [19] 251603 0
Dept of Medical Oncology
Flinders Medical Centre
Flinders Drive, Bedford Park, SA, 5042
Country [19] 251603 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259881 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 259881 0
Level 4, 10 St Andrews Place
East Melbourne, Victoria, 3002
Ethics committee country [1] 259881 0
Australia
Date submitted for ethics approval [1] 259881 0
07/07/2010
Approval date [1] 259881 0
03/09/2010
Ethics approval number [1] 259881 0
PMCC Protocol No: 10/56

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31779 0
A/Prof Michael Michael
Address 31779 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Australia
Country 31779 0
Australia
Phone 31779 0
+61 3 8559 7860
Fax 31779 0
Email 31779 0
Michael.Michael@petermac.org
Contact person for public queries
Name 15026 0
A/Prof Assoc Prof M Michael
Address 15026 0
Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
Country 15026 0
Australia
Phone 15026 0
+61 3 96561159
Fax 15026 0
+61 3 96561408
Email 15026 0
Michael.Michael@petermac.org
Contact person for scientific queries
Name 5954 0
A/Prof Assoc Prof M Michael
Address 5954 0
Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
Country 5954 0
Australia
Phone 5954 0
+61 3 96561159
Fax 5954 0
+61 3 96561408
Email 5954 0
Michael.Michael@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary