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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/NCT01223027




Registration number
NCT01223027
Ethics application status
Date submitted
30/09/2010
Date registered
18/10/2010
Date last updated
7/12/2015

Titles & IDs
Public title
Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
Scientific title
An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies
Secondary ID [1] 0 0
2009-015459-25
Secondary ID [2] 0 0
CTKI258A2302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dovitinib
Treatment: Drugs - Sorafenib

Experimental: Dovitinib + best supportive care (BSC) - Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.

Active Comparator: Sorafenib + BSC - Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.


Treatment: Drugs: Dovitinib
Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.

Treatment: Drugs: Sorafenib
Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Per Independent Central Radiology Review
Timepoint [1] 0 0
Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
until at least 386 deaths are documented in the clinical database.
Secondary outcome [2] 0 0
Progression Free Survival (PFS) Per Investigator's Radiology Review
Timepoint [2] 0 0
Until disease progression or discontinuation of treatment due to unacceptable toxicity
Secondary outcome [3] 0 0
Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review
Timepoint [3] 0 0
Until disease progression or discontinuation of treatment due to unacceptable toxicity
Secondary outcome [4] 0 0
Time to Definitive Worsening of Karnofsky Performance Status (KPS)
Timepoint [4] 0 0
from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier
Secondary outcome [5] 0 0
Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores
Timepoint [5] 0 0
from date of randomization, at least 2 score units
Secondary outcome [6] 0 0
Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%
Timepoint [6] 0 0
from date of randomization
Secondary outcome [7] 0 0
Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%
Timepoint [7] 0 0
from date of randomization
Secondary outcome [8] 0 0
Pre-dose Concentration in Plasma in Dovitinib
Timepoint [8] 0 0
Week 2 Day 5, Week 4 Day 5, Week 6 Day 5

Eligibility
Key inclusion criteria
- Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological
confirmation of clear cell carcinoma or a component of clear cell

- Patients must have received one and only one prior VEGF-targeted therapy and one and
only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted
therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and
one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus)

- Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.

- Patients must have had disease progression on or within 6 months of stopping the last
therapy.

- Patients must have at least one measurable lesion at baseline (by RECIST Criteria
Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance
Imaging (MRI).

- Karnofsky performance status = 70%

- Patients must have the following laboratory values:

- Absolute Neutrophil Count (ANC) = 1.5 x 109/L

- Platelets = 100 x 109/L

- Hemoglobin (Hgb) > 9 g/dL

- Serum total bilirubin: = 1.5 x ULN

- ALT and AST = 3.0 x ULN (Patients with known liver metastases: AST and ALT = 5.0
x ULN)

- Serum creatinine = 1.5 x ULN
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant
or metastatic setting.

- Patients who have previously received Dovitinib or brivanib in the neoadjuvant,
adjuvant or metastatic setting.

- Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the
brain is required at screening/baseline

- Patients with another primary malignancy within 3 years prior to starting study
treatment, with the exception of adequately treated basal cell carcinoma, squamous
cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine
cervix

- Patients who have received the last administration of an anticancer targeted small
molecule therapy = 2 weeks prior to starting study treatment (e.g. sunitinib,
pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the
side effects of such therapy

- Patients who have received the last administration of nitrosurea or mitomycin-C = 6
weeks prior to starting study treatment, or who have not recovered from the side
effects of such therapy

- Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or
intra-pelvic) = 4 weeks prior to starting study treatment or who have not recovered
from side effects of such therapy

- Patients with a history of pulmonary embolism (PE), or untreated deep venous
thrombosis (DVT) within the past 6 months

- Patients with concurrent severe and/or uncontrolled medical conditions which could
compromise participation in the study

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
564
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - St. Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [3] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [4] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [5] 0 0
Novartis Investigative Site - Footscray
Recruitment hospital [6] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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California
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Colorado
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Florida
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Georgia
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Hawaii
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Kansas
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Maryland
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Michigan
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Minnesota
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Nevada
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New Jersey
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New York
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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Linz
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Nuernberg
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Ulm
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Netherlands
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Bergen
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Norway
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Ålesund
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Poland
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Warszawa
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Riyadh
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Catalunya
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Comunidad Valenciana
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Galicia
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Islas Baleares
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Las Palmas de Gran Canaria
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Madrid
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Navarra
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Stockholm
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Sundsvall
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Uppsala
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Switzerland
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St. Gallen
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Thailand
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Bangkok
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Avon
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Colchester
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Manchester
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients
with metastatic renal cell cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01223027
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01223027