Trial Review

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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
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
Trial website
Trial related presentations / publications
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
ReubenB@adhb.govt.nz
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
kerint@adhb.govt.nz
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
reubenb@adhb.govt.nz

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
No additional documents have been identified.