| General information |
| Database: | DB00868 |
| Objective: | To evaluate the efficacy of mitogenactivated protein kinase/extracellular signalrelated kinase kinase inhibitor PD0325901 in advanced non small cell lung cancer patients who had experienced treatment failure after, or were refractory to, standard systemic therapy. |
| Authors: | Haura EB, et al |
| Title: | a phase II study of PD0325901, an oral MEK inhibitor, in previously treated patients with advanced non small cell lung cancer. |
| Journal: | Clin Cancer Res. |
| Year: | 2010 |
| PMID: | 20332327 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | PD0325901
|
| Target: | Dual specificity mitogenactivated protein kinase kinase
|
| 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: | a phase II study |
| Key Patients Feature: | advanced non small cell lung cancer patients who had experienced treatment failure after, or were refractory to, standard systemic therapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | this study initially evaluated 15 mg PD0325901 twice daily administered intermittently (3 weeks on/1 week off; schedule A). As this schedule was not well tolerated, a second schedule was introduced as follows: 5 days on/2 days off for 3 weeks, follotheyd by 1 week off (schedule B). |
| Primary End Point: | objective response. |
| Secondary End Point: | NA |
| Patients Number: | 34 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.8 months (1.51.9) |
| Median OS A vs. C: | 7.8 months (4.513.9) |
| Adverse Event(agent arm): | NA |
| Conclusions: | PD0325901 did not meet its primary efficacy end point. Future studies should focus on PD0325901 schedule, rational combination strategies, and enrichment of patient selection based on mode of action. |