Entry Detail
| General information | |
| Database: | DB00897 |
| Objective: | they studied the safety, clinical activity, and pharmacokinetics (PK) of AG013736, an oral receptor tyrosine kinase inhibitor of vascular endothelial cell growth factor, plateletderived growth factor, and cKit, in patients with advanced cancer. |
| Authors: | Rugo HS, et al |
| Title: | Phase I trial of the oral antiangiogenesis agent AG013736 in patients with advanced solid tumors: pharmacokinetic and clinical results. |
| Journal: | J Clin Oncol. |
| Year: | 2005 |
| PMID: | 16027439 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | AG013736 |
| Target: | Macrophage colonystimulating factor 1 Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| 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 trial |
| Key Patients Feature: | All patients were more than and equal to 18 years of age with histologically confirmed advanced nonhematologic cancer refractory to standard therapy or for which no effective therapy was available. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received fixed doses of AG013736 orally in 28day cycles. In the first cohort, patients initially received two single test doses of AG013736 (10 and 30 mg); subsequent dosing was determined by individual PK parameters. Doses in subsequent cohorts were assigned by using a traditional doseescalation/deescalation rule based on observed toxicities in the current and previous cohorts. PK analysis included evaluation of the effect of food and antacid. |
| Primary End Point: | DLT¡¢MTD¡¢PK |
| Secondary End Point: | NA |
| Patients Number: | 36 |
| Trial Results | |
| DLT_MTD: | The doselimiting toxicities observed included hypertension, hemoptysis, and stomatitis and were seen primarily at the higher dose levels.The MTD and recommendedphase II dose of AG013736 is 5 mg BID in the fasted state |
| 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): | NA |
| Conclusions: | In this study, they have demonstrated clinical activity and safety of AG013736 in patients with advanced solid tumors and identified the dose forphase II testing. The uniquephase I study design allotheyd early identification of important absorption and metabolic issues critical tophase II testing of this agent. |