Phase 2
Completed N=213
Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00835978 ↗
Enrolled (actual)
213
Serious AEs
37.6%
Results posted
May 2014
Primary outcomePrimary: Objective Response Rate (ORR) - Percentage of Participants With Objective Response — 53.6; 33.9; 59.3; 48.4 Percentage of Participants — p=0.0189
Summary
Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) - Percentage of Participants With Objective Response |
53.6; 33.9; 59.3; 48.4 | 0.0189 sig |
| SECONDARY Progression-Free Survival (PFS) |
14.5; 15.7; 16.6; 14.6 | 0.2444 |
| SECONDARY Duration of Response (DR) |
NA; 21.2; 23.3 | — |
| SECONDARY Overall Survival (OS) |
42.7; 30.4; 41.6 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Axitinib |
31.74; 23.05 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, |
2.04; 2.00 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib |
105.33; 78.44 | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib |
258.68; 161.38 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) for Axitinib |
2.48; 2.81 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Axitinib |
54.15; 61.93 | — |
| SECONDARY Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib |
158.18; 216.62 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure |
-4.3; -2.9; -1.8; 3.8; 4.1; 11.5 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure |
-1.6; -2.6; 0.5; 4.8; 3.0; 11.5 | — |
| SECONDARY Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline |
23584; 28544; 29663; 346815; 455238; 327567 | — |
| SECONDARY Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline |
2.3; 3.7; 2.2; 1.3; 4.4; 1.3 | — |
| SECONDARY Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+ |
74668; 76258; 77437; 333760; 380886; 442642 | — |
| SECONDARY Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline |
2.7; 1.6; 1.5; 1.4; 2.2; 2.5 | — |
| SECONDARY ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms |
85.7; 22.2; 42.9; 54.5; 35.0; 65.9 | — |
| SECONDARY PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms |
NA; 11.50; 7.33; 11.07; 9.67; 16.59 | — |
Eligibility Criteria
Inclusion Criteria
- metastatic renal cell carcinoma (kidney cancer) with clear cell component
- no prior systemic therapy (including no prior adjuvant or neoadjuvant)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Blood Pressure < or = 140/90mmHg
Exclusion Criteria
- brain/CNS metastasis
- using more than 2 blood pressure medications
Data sourced from ClinicalTrials.gov (NCT00835978). 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.