Entry Detail
| General information | |
| Database: | DB00092 |
| Objective: | This proofofconcept study examined safety and efficacy of shortterm, preoperative pazopanib monotherapy in patients with operable stage I/II non small cell lung cancer. |
| Authors: | Altorki N, et al |
| Title: | Phase II proofofconcept study of pazopanib monotherapy in treatmentnaive patients with stage I/II resectable non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2010 |
| PMID: | 20516450 |
| Trial Design | |
| Clinical Trial Id: | NCT00367679 |
| Agent: | pazopanib |
| Target: | Plateletderived growth factor receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | earlystage, resectable, non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II proofofconcept study |
| Key Patients Feature: | Patients with earlystage, resectable, non small cell lung cancer (non small cell lung cancer), Of 35 patients enrolled, 33 (94%) had clinical stage I non small cell lung cancer and two (6%) had clinical stage II non small cell lung cancer. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients scheduled for resection received oral pazopanib 800 mg/d for 2 to 6 weeks preoperatively |
| Primary End Point: | Tumor response was measured by highresolution computed tomography, permitting estimation of change in tumor volume and diameter. |
| Secondary End Point: | NA |
| Patients Number: | 35 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Thirty patients (86%) achieved tumorvolume reduction after pazopanib treatment. Two patients achieved tumorvolume reduction > or = 50%, and three patients had partial response |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Pazopanib was generally well tolerated. The most common adverse events included grade 2 hypertension, diarrhea, and fatigue. One patient developed pulmonary embolism 11 days after surgery. |
| Conclusions: | Shortduration pazopanib was generally well tolerated and demonstrated singleagent activity in patients with earlystage non small cell lung cancer. Several target genes were dysregulated after pazopanib treatment, validating targetspecific response and indicating a persistent pazopanib effect on lung cancer tissue. Further clinical evaluation of pazopanib in non small cell lung cancer is planned. |