| General information |
| Database: | DB01015 |
| Objective: | they conducted a phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of CKD732 [6O(4dimethylaminoethoxy) cinnamoyl fumagillol hemioxalate] in combination with capecitabine and oxaliplatin (XELOX) in nine metastatic colorectal cancer patients who had progressed on irinotecanbased chemotherapy. |
| Authors: | Shin SJ, et al |
| Title: | a phase Ib pharmacokinetic study of the antiangiogenic agent CKD732 used in combination with capecitabine and oxaliplatin (XELOX) in metastatic colorectal cancer patients who progressed on irinotecanbased chemotherapy. |
| Journal: | Invest New Drugs. |
| Year: | 2012 |
| PMID: | 21188464 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | beloranib
|
| Target: | Methionine aminopeptidase2
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | CKD732 used + capecitabine + oxaliplatin (XELOX) |
| Study Type: | a phase Ib pharmacokinetic study |
| Key Patients Feature: | metastatic colorectal cancer patients who progressed on irinotecanbased chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Using a doseescalation schedule, CKD732 doses of 2, 5, or 10 mg/m(2)/d were administered twice weekly for 2 weeks, followed by a 1week rest. Oxaliplatin (130 mg/m(2)) was administered on day 1, and capecitabine (1, 000 mg/m(2) twice a day) was orally administered for 14 days of a 3week cycle. |
| Primary End Point: | Phase II recommended dose |
| Secondary End Point: | NA |
| Patients Number: | 2 |
| Trial Results |
| DLT_MTD: | In the group given the 10 mg/m(2)/d dose, two patients experienced dose limiting toxicities (one had grade 3 nausea, insomnia, and fatigue; the other had grade 3 insomnia). The maximum tolerated dose was 10 mg/m(2)/d, and the clinically recommended dose was 5 mg/m(2)/d for CKD732 in combination with XELOX. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | 157 days (95% confidence interval, 78-198 days) for all evaluable patients. |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | In the group given the 10 mg/m(2)/d dose, two patients experienced dose limiting toxicities (one had grade 3 nausea, insomnia, and fatigue; the other had grade 3 insomnia). The maximum tolerated dose was 10 mg/m(2)/d, and the clinically recommended dose was 5 mg/m(2)/d for CKD732 in combination with XELOX. |
| Conclusions: | Thephase II recommended dose of CKD732 was determined to be 5 mg/m(2)d, and this dose was safely combined with a conventional dose of capecitabine and oxaliplatin in this patient population. Further studies on the effects of CKD732 in combination with XELOX and other chemotherapies using a larger study population are warranted. |