drugset / Trial / NCT01681472
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
RandomizedParallel-groupSingle-blindTreatment
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
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 |