Phase 3
N=492
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Kidney Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00920816 ↗Enrolled (actual)
492
Serious AEs
40.4%
Results posted
Feb 2014
Primary outcome: Primary: Progression Free Survival (PFS): First-Line Participants — 10.1; 6.5 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Axitinib (AG-013736) (Drug); Sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS): First-Line Participants |
10.1; 6.5 | — |
| PRIMARY Progression Free Survival (PFS): Second-Line Participants |
6.5; 4.8 | — |
| SECONDARY Percentage of Participants With Objective Response (OR): First-Line Participants |
32.3; 14.6 | — |
| SECONDARY Percentage of Participants With Objective Response (OR): Second-Line Participants |
23.7; 10.1 | — |
| SECONDARY Duration of Response (DR): First-Line Participants |
14.7; 14.3 | — |
| SECONDARY Duration of Response (DR): Second-Line Participants |
NA; 8.7 | — |
| SECONDARY Overall Survival (OS): First-Line Participants |
NA; NA | — |
| SECONDARY Overall Survival (OS): Second-Line Participants |
17.2; 18.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically documented metastatic renal cell cancer with a component of clear cell histology.
- Evidence of measurable disease.
- Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
Exclusion Criteria
- Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
- Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
Data sourced from ClinicalTrials.gov (NCT00920816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.