| General information |
| Database: | DB00072 |
| Objective: | Currently, crizotinib is the only drug that has been approved for treatment of ALKrearranged non small cell lung cancer (non small cell lung cancer). they aimed to study the activity and safety of CH5424802, a potent, selective, and orally available ALK inhibitor. |
| Authors: | Seto T, et al |
| Title: | CH5424802 (RO5424802) for patients with ALKrearranged advanced non small cell lung cancer (AF001JP study): a singlearm, openlabel, phase 12 study. |
| Journal: | Lancet Oncol. |
| Year: | 2013 |
| PMID: | 23639470 |
| Trial Design |
| Clinical Trial Id: | Japan Pharmaceutical Information Center, JapicCTI101264 |
| Agent: | alectinib
|
| Target: | ALK inhibition including activity againstL1196M, G1269A, C1156Y, and F1174Lmutations
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced ALKrearranged non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase I/II AF00IJP multicentre, singlearm, openlabel, study |
| Key Patients Feature: | ALK inhibitornaive patients with ALKrearranged advanced non small cell lung cancer from 13 hospitals in Japan |
| Biomarker: | ALKpositive |
| Biomark Analysis: | CH5424802 is well tolerated and highly active in patients with advanced ALKrearranged non small cell lung cancer |
| Control Group Info: | single arm |
| Treatment Info: | In the phase 1 portion of the study, patients received CH5424802 orally twice daily by dose escalation. In the phase 2 portion of the study, patients received CH5424802 at the recommended dose identified in the phase 1 portion of the study orally twice a day. |
| Primary End Point: | The primary endpoints of the phase 1 were dose limiting toxicity (DLT), maximum tolerated dose (MTD), and pharmacokinetic parameters. The primary endpoint of the phase 2 was the proportion of patients who had an objective response. |
| Secondary End Point: | NA |
| Patients Number: | 46 |
| Trial Results |
| DLT_MTD: | MDT:300 mg twice daily |
| Objective Response Rate: | 93.5%, 95% CI 82.198.6 |
| 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): | Treatmentrelated adverse events of grade 3:26%;Serious adverse events:11%; |
| Conclusions: | CH5424802 is well tolerated and highly active in patients with advanced ALKrearranged non small cell lung cancer |