Overview

This trial is active, not recruiting.

Condition kidney neoplasms
Treatments axitinib (ag-013736), sorafenib
Phase phase 3
Targets RAF, FLT-3, KIT, PDGF, VEGF
Sponsor Pfizer
Start date September 2008
End date August 2010
Trial size 723 participants
Trial identifier NCT00678392, 2008-001451-21, A4061032, AXIS, AXIS TRIAL

Summary

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
axitinib (ag-013736)
axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing
(Active Comparator)
sorafenib
sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing

Primary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years
Percentage of Participants With Objective Response (OR)
time frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years
Duration of Response (DR)
time frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
time frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)
FKSI-Disease Related Symptoms (FKSI-DRS) Score
time frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)
Euro Quality of Life Questionnaires- 5 Dimension (EQ-5D) Index Score
time frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)
EQ-5D Visual Analog Scale (EQ-5D VAS)
time frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis - Evidence of measurable disease - Must have failed one prior systemic first-line regimen for metastatic renal cell cancer Exclusion Criteria: - Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy - Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug

Additional Information

Official title Axitinib (Ag-013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Pfizer.