Entry Detail
| General information | |
| Database: | DB00973 |
| Objective: | To assess the maximumtolerated dose (MTD), doselimiting toxicity (DLT), safety, and tolerability of the 24h continuous intravenous (CIV) infusion of MK0457, a novel panAurora kinase inhibitor, in patients with advanced solid tumors and to determine the bioavailability of an oral dose of 100 mg MK0457. |
| Authors: | Traynor AM, et al |
| Title: | Phase I dose escalation study of MK0457, a novel Aurora kinase inhibitor, in adult patients with advanced solid tumors. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2011 |
| PMID: | 20386909 |
| Trial Design | |
| Clinical Trial Id: | NCT00104351 |
| Agent: | MK0457 |
| Target: | Aurora kinase A Serine/threonine protein kinase 12 Protooncogene tyrosineprotein kinase LCK |
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase I dose escalation study |
| Key Patients Feature: | patients with advanced solid tumors |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | MK0457 was administered as a 24h CIV infusion every 21 days. Dose escalation proceeded per toxicity criteria. A 100mg oral dose was administered to seven patients 48 h prior to the CIV infusion dose of 64 mg/m(2)/h. |
| Primary End Point: | maximumtolerated dose (MTD), doselimiting toxicity (DLT), safety, and tolerability |
| Secondary End Point: | NA |
| Patients Number: | 27 |
| Trial Results | |
| DLT_MTD: | Dose limiting toxicity at 96 mg/m2/hr included grade 4 neutropenia and grade 3 herpes zoster. The MTD was identified as 64 mg/m2/hr. |
| Objective Response Rate: | NA |
| 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): | The most common adverse events were nausea, vomiting, diarrhea and fatigue. |
| Conclusions: | MK0457 was well tolerated in this schedule. Almost half the patients attained stable disease. Further development of this class of agents will likely occur in combination with other anticancer treatments. |