Entry Detail
| General information | |
| Database: | DB00820 |
| Objective: | To evaluate the efficacy of the panERBB inhibitor, CI1033, in platinumrefractory or recurrent advancedstage non small cell lung cancer (non small cell lung cancer). |
| Authors: | J nne PA, et al |
| Title: | Multicenter, randomized, phase II trial of CI1033, an irreversible panERBB inhibitor, for previously treated advanced non smallcell lung cancer. |
| Journal: | J Clin Oncol |
| Year: | 2007 |
| PMID: | 17761977 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | CI1033 |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 AKT1 protein kinase Receptor proteintyrosine kinase erbB4 |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Multicenter, randomized, phase II trial |
| Key Patients Feature: | patients with advancedstage non small cell lung cancer who experienced treatment failure after or were refractory to platinumbased chemotherapy. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Three oral CI1033 doses were evaluated in 21day dosing cycles: 50 mg daily for 21 consecutive days, 150 mg daily for 21 consecutive days, and 450 mg daily for 14 consecutive days follotheyd by 7 days of no treatment. |
| Primary End Point: | 1year survival rate. |
| Secondary End Point: | NA |
| Patients Number: | 166 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | The response rates were 2%, 2%, and 4% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | The 1year survival rates were 29%, 26%, and 29%, respectively, in the three arms. |
| Adverse Event(agent arm): | NA |
| Conclusions: | CI1033 had modest activity in unselected non small cell lung cancer patients but did not meet its primary end point. Future studies should focus on identifying methods of patient selection. |