drugset / Trial / NCT01397305
An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether an optimal dose of \[6R\] 5,10-methylenetetrahydrofolate (arfolitixorin) in combination with pemetrexed are effective in pre-operative treatment of patients with resectable rectal cancer.
Timeline
- Start
- 2011-04-14
- Primary completion
- 2014-10-16
- Completion
- 2014-10-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arfolitixorin | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Arfolitixorin | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Arfolitixorin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Arfolitixorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Arfolitixorin | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |