How does the genetic make-up of renal cell cancer affect the activity of dovitinib?
Phase 2
Completed
- Conditions
- Renal cell cancerCancer - Kidney
- Registration Number
- ACTRN12612000140853
- Lead Sponsor
- Auckland District Health Board (ADHB)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Advanced / metastatic renal cell (clear cell) carcinoma
FFPE tumour tissue available for gene status analysis
ECOG PS = 1
Adequate organ function
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome 1: Progression-free survival (PFS) as assessed by RECIST 1.1.[Baseline, every 9 weeks until week 54, then every 12 weeks until disease progression]
- Secondary Outcome Measures
Name Time Method Secondary outcome 1: Response rate (RR) using RECIST 1.1[Baseline, every 9 weeks until week 54, then every 12 weeks until disease progression];Secondary outcome 2: Overall Survival (OS)[24 months];Secondary outcome 3: Proportion of subjects who are FGFR-1,-2,-3 amplified using gene analysis by Fluorescent in-situ hybridization[baseline, disease progression];Secondary outcome 4: Efficacy (PFS, RR, OS) by FGFR gene amplification status as measured by Spearman's rho correlation coefficient[8 months, 12 months, 24 months];Safety profile of dovitinib (specifically in this first-line patient population) using NCI CTCAE v4.0[weekly for weeks 1-3; then every 3 weeks until disease progression; then 3-monthly for up to 2 years]