PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
Summary
The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).
Timeline
- Start
- 2012-09
- Primary completion
- 2013-08
- Completion
- 2013-08
Outcome
Mixed primary results
registry MEAN Levoleucovorin 200 mg/m2: 1871 (Standard Deviation 1159) pmol/g NCT01681472 ↗
registry MEAN Modufolin 200 mg/m2: 4725 (Standard Deviation 2210) pmol/g NCT01681472 ↗
registry analysis (superiority test); Levoleucovorin 200 mg/m2 vs Modufolin 200 mg/m2; p = 0.0074; Wilcoxon (Mann-Whitney) NCT01681472 ↗
registry MEAN Levoleucovorin 200 mg/m2: 3574 (Standard Deviation 2415) pmol/g NCT01681472 ↗
registry MEAN Modufolin 200 mg/m2: 4396 (Standard Deviation 1858) pmol/g NCT01681472 ↗
registry analysis (superiority test); Levoleucovorin 200 mg/m2 vs Modufolin 200 mg/m2; p = 0.3184; Wilcoxon (Mann-Whitney) NCT01681472 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arfolitixorin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Arfolitixorin | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Levoleucovorin | Unknown | 60 mg/m2 | Intravenous |
| Comparator | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |