CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
6R-MTHF (arfolitixorin) 200 mg/m2 +3 moredrug
Likely dose
6R-MTHF (arfolitixorin) 200 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01681472
NCT01681472Phase 2Completed
CompareCT.gov

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

Isofol Medical AB·interventional·Posted Sep 10, 2012·Updated Sep 25, 2020

In Brief

A Phase 2 clinical trial evaluating 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2, and 2 other interventions for Colonic Neoplasms. Completed, enrolled 32 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonic Neoplasms
CountriesSweden
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2012
Enrollment StartSep 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.8 years ago

Interventions

6R-MTHF (arfolitixorin) 200 mg/m2drug

i.v. bolus injection

Levoleucovorin 200 mg/m2drug

i.v. bolus injection

6R-MTHF (arfolitixorin) 60 mg/m2drug

i.v. bolus injection

Levoleucovorin 60 mg/m2drug

i.v. bolus injection