Phase 3
Completed N=723
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Source: ClinicalTrials.gov NCT00678392 ↗Enrolled (actual)
723
Serious AEs
38.2%
Results posted
Mar 2012
Primary outcomePrimary: Progression-Free Survival (PFS) — 6.7; 4.7 Months — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
6.7; 4.7 | <0.0001 sig |
| SECONDARY Overall Survival (OS) |
20.1; 19.2 | 0.3744 |
| SECONDARY Objective Response Rate (ORR) |
19.4; 9.4 | 0.0001 sig |
| SECONDARY Duration of Response (DR) |
11.0; 10.6 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
96.1; 98.0; 40.7; 35.8 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) by Severity |
3.9; 3.1; 20.1; 21.7; 47.6; 52.4 | — |
| SECONDARY Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
92.2; 95.2; 15.3; 13.8 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology |
93; 112; 19; 41; 1; 11 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry |
65; 57; 8; 6; 1; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis |
45; 35; 1; 0; 0; 0 | — |
| SECONDARY Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score |
43.199; 43.339; 42.351; 41.668; 42.590; 42.424 | — |
| SECONDARY Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score |
28.874; 28.975; 28.211; 28.399; 28.640; 28.640 | — |
| SECONDARY Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score |
0.732; 0.731; 0.716; 0.696; 0.722; 0.709 | — |
| SECONDARY Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS) |
70.560; 70.351; 69.003; 67.606; 69.843; 69.712 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00678392). 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. Informational only — not medical advice.