Phase 2
Completed N=118
A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
Non-Small Cell Lung Carcinoma · Adenocarcinoma
Source: ClinicalTrials.gov NCT00600821 ↗
Enrolled (actual)
118
Serious AEs
42.7%
Results posted
May 2012
Primary outcomePrimary: Progression Free Survival (PFS) — 5.7; 6.1 Months — p=0.639
Summary
To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
5.7; 6.1 | 0.639 |
| SECONDARY Overall Survival (OS) |
10.6; 13.3 | 0.699 |
| SECONDARY Percentage of Participants With Objective Response (OR) |
29.3; 43.3 | 0.9422 |
| SECONDARY Duration of Response (DR) |
4.4; 7.0 | — |
| SECONDARY Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736) |
— | — |
| SECONDARY European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score |
66.29; 75.00; 67.45; 75.47; 65.78; 78.16 | — |
| SECONDARY European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score |
37.50; 38.42; 30.67; 30.19; 28.98; 28.37 | — |
| SECONDARY Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood |
— | — |
| SECONDARY Circulating Endothelial Cells (CEC) in Blood: Total CEC |
46815.38; 16960.41; 11780.15; 21882.41; 29229.09; 40507.36 | — |
| SECONDARY Circulating Endothelial Cells (CEC) in Blood |
1936317.98; 1764577.67; 1822095.74; 1810049.32; 1767065.44; 2090673.60 | — |
| SECONDARY Plasma Concentration of Soluble Proteins |
49740.29; 49544.15; 53095.48; 55801.39; 52979.39; 55729.65 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced non squamous cell, lung cancer
- No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment
Exclusion Criteria
- Prior therapy for advanced lung cancer
- The need for blood-thinners
- Coughing up blood
Data sourced from ClinicalTrials.gov (NCT00600821). 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.