| General information |
| Database: | DB01020 |
| Objective: | they conducted a phase I trial of the antiangiogenic agent 6O(4dimethylaminoethoxy) cinnamoyl fumagillol hemioxalate (CKD732). Our aims were to determine the maximum tolerated dose (MTD), pharmacokinetics (PK), and safety profiles as well as identify the biologically active dose (BAD) from ex vivo pharmacodynamics (PD) and biomarkers of CKD732 |
| Authors: | Shin SJ, et al |
| Title: | a phase I pharmacokinetic and pharmacodynamic study of CKD732, an antiangiogenic agent, in patients with refractory solid cancer. |
| Journal: | Invest New Drugs. |
| Year: | 2010 |
| PMID: | 19585083 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | beloranib
|
| Target: | Methionine aminopeptidase2
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase I pharmacokinetic and pharmacodynamic study |
| Key Patients Feature: | patients with refractory solid cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Using a dose escalation schedule, 19 patients with refractory solid tumors were enrolled at dose levels of CKD732 ranging from 1 to 15 mg/m(2) given twice weekly for 2 weeks follotheyd by a 1week rest. No treatmentrelated deaths occurred in this study. |
| Primary End Point: | maximum tolerated dose (MTD), pharmacokinetics (PK), and safety profiles as well as biologically active dose (BAD) |
| Secondary End Point: | NA |
| Patients Number: | 19 |
| Trial Results |
| DLT_MTD: | Confusion and insomnia were doselimiting toxicities (DLTs), and MTD was 15 mg/m(2). |
| Objective Response Rate: | NA |
| Disease Control Rate: | 35.70% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Most adverse events were associated with advanced cancer or preexisting comorbidities. |
| Conclusions: | The results from this study showed an MTD of 15 mg/m(2) and a BAD of 5 mg/m(2). |