Clinical trial · Interventional
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
A Single-Blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® (60 or 200mg/m2) Compared to Levoleucovorin (60 or 200mg/m2) in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6R-MTHF (arfolitixorin) 200 mg/m2 | Drug | — | UNRESOLVED |
| 6R-MTHF (arfolitixorin) 60 mg/m2 | Drug | — | UNRESOLVED |
| Levoleucovorin 200 mg/m2 | Drug | Levoleucovorin | ALIAS |
| Levoleucovorin 60 mg/m2 | Drug | Levoleucovorin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Levoleucovorin 200 mg/m2
- description
- One i.v. bolus injection of study drug after the patient has been anaesthetized.
- interventionNames
- Drug: Levoleucovorin 200 mg/m2
- type
- ACTIVE_COMPARATOR
- label
- Levoleucovorin 60 mg/m2
- description
- One i.v. bolus injection of study drug after the patient has been anaesthetized.
- interventionNames
- Drug: Levoleucovorin 60 mg/m2
- type
- EXPERIMENTAL
- label
- 6R-MTHF 200 mg/m2
- description
- One i.v. bolus injection of study drug after the patient has been anaesthetized.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: * Operable colon cancer amenable to curative surgery. * Performance status of 0 to 1 * Informed consent form * Patients must be at least 18 years of age. Main Exclusion Criteria: * Any concurrent other anti-tumor therapy * Any prohibited concomitant medication within 30 days of surgery * Pregnancy or breast-feeding. * Second primary malignancy
References
Publications (0)
Data not yet available