Carcinoma, Renal Cell, Clear Cell Renal Cell Carcinoma
Conditions
Brief summary
Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.
Detailed description
Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor-α, and c-kit. The trial of comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS) was an international randomized Phase III study designed for registration purposes. This trial randomized 723 metastatic renal cell carcinoma patients with any prognostic features to axitinib or sorafenib in the second-line setting and demonstrated significant clinical benefit of axitinib. Aim of present FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.
Interventions
DRUGaxitinib
Initial dose of axitinib: 5 mg orally twice a day. Maintenance dose of axitinib: Increase or decrease dose based on individual safety and tolerability. Dose range of axitinib: 2 to 10 mg twice a day.
Sponsors
Kidney Cancer Research Bureau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Principle Inclusion Criteria: * Histologic confirmation of Renal cell carcinoma with a clear cell component * Patients must have measurable disease * Previous treatment with sunitinib or pazopanib * Favorable prognosis according to IMDC criteria * Must have available tumor tissue for submission * Subjects must also meet various laboratory parameters for inclusion * Patients must give written informed consent prior to initiation of therapy
Exclusion criteria
* Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events * Patients who have history of uncompensated diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 10 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 24 months | — |
| Overall survival | 24 months | — |
| Rate of treatment-related serious adverse events | 24 months | Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 |
Countries
Russia
Outcome results
None listed