| General information |
| Database: | DB00143 |
| Objective: | The safety, tolerability, pharmacokinetics (PK), and antitumor activity of MK2206 was evaluated in Japanese patients with advanced solid tumors. |
| Authors: | Doi T, et al |
| Title: | Phase 1 pharmacokinetic study of the oral panAKT inhibitor MK2206 in Japanese patients with advanced solid tumors. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2015 |
| PMID: | 26104654 |
| Trial Design |
| Clinical Trial Id: | NCT01071018. |
| Agent: | MK2206
|
| Target: | AKT1 protein kinase
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, nonrandomized, multicenterphase I study |
| Key Patients Feature: | Advanced solid tumor in Japanese patients |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received a single oral dose of MK2206 according to an every other day (QOD) dosing schedule or a once weekly (QW) dosing schedule in repeating 28day treatment cycles, with a 7day rest after only the first cycle. |
| Primary End Point: | MDT, DLT, PK, PD, PR, SD, and Aes |
| Secondary End Point: | NA |
| Patients Number: | 24 |
| Trial Results |
| DLT_MTD: | One patient experienced a DLT at 60 mg QOD, and three patients experienced DLTs at 200 mg QW. No DLTs were observed at 45 mg QOD or at 135 mg QW. The DLTs included mucosal inflammation, hyponatremia, face edema, erythema multiforme, and hyperglycemia. |
| Objective Response Rate: | No tumor responses were observed |
| Disease Control Rate: | six patients exhibited stable disease lasting longer than 4 months. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Common adverse events related to MK2206 included rash, an elevated insulin cpeptide level, stomatitis, pyrexia, eosinophilia, leukopenia, and hyperglycemia. |
| Conclusions: | MK2206 has an acceptable safety profile in Japanese patients with advanced solid tumors and warrants further investigation. |