Health Condition 1: null- Kidney Neoplasms
Conditions
Interventions
Intervention1: Axitinib (AG-013736): axitinib will be given at a starting dose of 5 mg BID with continuous dosing
Control Intervention1: Sorafenib: sorafenib will be given at a dose of 400 mg BID with
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No 1. Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis . 2.Evidence of measurable disease 3.Must have failed one prior systemic first-line regimen for metastatic renal cell cancer Kindly note that there is no upper age limit for inclusion criteria for this trial
Exclusion criteria
Exclusion criteria: 1. Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy 2. Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free SurvivalTimepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response in Each ArmTimepoint: 3 Years;Kidney Specific Symptoms tested by Functional Assessment of Cancer Therapy Kidney Symptom Index [FKSI] and Health Status EQ-5D [European Quality of Life Scale]Timepoint: 3 Years ;Overall SurvivalTimepoint: 3 years;Response RateTimepoint: 3 years;Safety and Tolerability on Axitinib: number of patients with metastatic renal cell cancer with incidence of drug related adverse eventsTimepoint: 3 Years | — |
Countries
Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Ireland, Italy, Japan, Other, Poland, Republic of Korea, Russian Federation, Singapore, Slovakia, Spain, Sweden, United Kingdom, United States of America
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed