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Trial registered on ANZCTR


Registration number
ACTRN12612000140853
Ethics application status
Approved
Date submitted
23/01/2012
Date registered
1/02/2012
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
How does the genetic make-up of renal cell cancer affect the activity of dovitinib?
Scientific title
Dovitinib In 1st-Line Renal Cell Carcinoma, an Investigation into tumour Gene status and Correlation with Efficacy – 1st exploratory study
Secondary ID [1] 279773 0
CTKI258AAU02T (internal Novartis trial ID number)
Universal Trial Number (UTN)
U1111-1127-6276
Trial acronym
DILIGENCE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal cell cancer 285655 0
Condition category
Condition code
Cancer 285831 285831 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dovitinib 500 mg taken orally once daily 5 days on / 2 days off, until disease progression
Intervention code [1] 284096 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286341 0
Primary outcome 1: Progression-free survival (PFS) as assessed by RECIST 1.1.
Timepoint [1] 286341 0
Baseline, every 9 weeks until week 54, then every 12 weeks until disease progression
Secondary outcome [1] 295634 0
Secondary outcome 1: Response rate (RR) using RECIST 1.1
Timepoint [1] 295634 0
Baseline, every 9 weeks until week 54, then every 12 weeks until disease progression
Secondary outcome [2] 295635 0
Secondary outcome 2: Overall Survival (OS)
Timepoint [2] 295635 0
24 months
Secondary outcome [3] 295636 0
Secondary outcome 3: Proportion of subjects who are FGFR-1,-2,-3 amplified using gene analysis by Fluorescent in-situ hybridization
Timepoint [3] 295636 0
baseline, disease progression
Secondary outcome [4] 295637 0
Secondary outcome 4: Efficacy (PFS, RR, OS) by FGFR gene amplification status as measured by Spearman's rho correlation coefficient
Timepoint [4] 295637 0
8 months, 12 months, 24 months
Secondary outcome [5] 295638 0
Safety profile of dovitinib (specifically in this first-line patient population) using NCI CTCAE v4.0
Timepoint [5] 295638 0
weekly for weeks 1-3; then every 3 weeks until disease progression; then 3-monthly for up to 2 years

Eligibility
Key inclusion criteria
Advanced / metastatic renal cell (clear cell) carcinoma
FFPE tumour tissue available for gene status analysis
ECOG PS = 1
Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled brain metastases
Another primary malignancy < 3 years prior to starting study treatment
Prior systemic anticancer treatment
Uncontrolled hypertension
Impaired cardiac function; clinically significant cardiac disease
Concurrent severe and/or uncontrolled concomitant medical conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2012
Actual
13/03/2012
Date of last participant enrolment
Anticipated
Actual
10/05/2013
Date of last data collection
Anticipated
Actual
17/08/2015
Sample size
Target
30
Accrual to date
Final
31
Recruitment outside Australia
Country [1] 4072 0
New Zealand
State/province [1] 4072 0

Funding & Sponsors
Funding source category [1] 284557 0
Commercial sector/Industry
Name [1] 284557 0
Novartis Pharmaceuticals Australia Pty Limited
Country [1] 284557 0
Australia
Primary sponsor type
Hospital
Name
Auckland District Health Board (ADHB)
Address
Auckland City Hospital
Park Road
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 283478 0
None
Name [1] 283478 0
Address [1] 283478 0
Country [1] 283478 0
Other collaborator category [1] 260468 0
University
Name [1] 260468 0
University of Auckland
Address [1] 260468 0
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand
Country [1] 260468 0
New Zealand
Other collaborator category [2] 260469 0
Other
Name [2] 260469 0
IGENZ Ltd
Address [2] 260469 0
PO Box 106-542
Auckland 1143
New Zealand
Country [2] 260469 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286537 0
Northern X Regional Ethics Committee
Ethics committee address [1] 286537 0
Private Bag 92522
Wellesley St
Auckland 1141
New Zealand
Ethics committee country [1] 286537 0
New Zealand
Date submitted for ethics approval [1] 286537 0
28/11/2011
Approval date [1] 286537 0
14/01/2012
Ethics approval number [1] 286537 0

Summary
Brief summary
The main purpose of this study is to find out how useful dovitinib is when given as the initial treatment to participants with advanced kidney cancer, that has spread to other parts of the body. The usefulness of dovitinib will be assessed by: how long the disease is controlled while participants are receiving the drug, the proportion of participants who get a reduction in the size of their tumours and how long participants live (both while on dovitinib and on any subsequent therapy they may receive).
If participants have secondary disease in the bones, the study will evaluate how useful dovitinib is in controlling this site of disease. In addition, this study will look for changes in the genetic makeup of tumour cells and see if some of these changes are associated with a benefit from dovitinib. The study will also compare and contrast the genetic changes in the primary tumour cells with cells from secondary tumour specimens, and with cells from tumour specimens taken if a participant’s disease has worsened. The purpose of the latter is to identify possible ways in which the tumour becomes resistant to the study drug.
Trial website
Trial related presentations / publications
ASCO GU 2014 Dovitinib In 1st-Line Renal Cell Carcinoma, an Investigation into tumour GENe status and Correlation with Efficacy – 1st exploratory study. Abstract # 443

ASCO 2014 Dovitinib In 1st-Line Renal Cell Carcinoma, an Investigation into tumour GENe status and Correlation with Efficacy – 1st exploratory study. Abstract #4569
Public notes

Contacts
Principal investigator
Name 33664 0
Dr Reuben Broom
Address 33664 0
Auckland City Hospital Park Rd, Grafton, Auckland 1023, NZ
Country 33664 0
New Zealand
Phone 33664 0
006493074949
Fax 33664 0
Email 33664 0
[email protected]
Contact person for public queries
Name 16911 0
Kerin Thompson, Project Manager
Address 16911 0
Adult Oncology Research Centre
Regional Cancer and Blood Services
Auckland City Hospital
2 Park Rd
Grafton
Auckland 1023
New Zealand
Country 16911 0
New Zealand
Phone 16911 0
+64 9 307 4949 ext 25197
Fax 16911 0
+64 9 375 4391
Email 16911 0
[email protected]
Contact person for scientific queries
Name 7839 0
Dr Reuben Broom, Medical Oncologist
Address 7839 0
Oncology Department
Regional Cancer and Blood Services
Auckland City Hospital
2 Park Rd
Grafton
Auckland 1023
New Zealand
Country 7839 0
New Zealand
Phone 7839 0
+64 9 307 4949 ext 23868
Fax 7839 0
+64 9 375 4391
Email 7839 0
[email protected]

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
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