Trial intelligence / Profile preview

Modufolin vs Levoleucovorin PK/PD in Colon Cancer

NCT01681472Phase 2

Key facts

Status: Completed
Start: Sep 2012
Primary completion: Aug 2013
Countries: 1
Sponsor: Isofol Medical
Modality: Small Molecules

Drugs: arfolitixorin
Conditions: colon cancer

Overview

Phase 2, randomised, single-blind trial of arfolitixorin in colon cancer (4 arms), sponsored by Isofol Medical. Primary endpoints: Concentration of [6R]-5,10-methylene-THF in Tumor Tissue at 24 hours, Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue at 24 hours and 6 more. Started Sep 2012; status: completed.

Design

4 arms

Study design: RandomizedSingle-blind

Levoleucovorin 200 mg/m2
Single i.v. bolus of Levoleucovorin 200 mg/m2
Levoleucovorin 60 mg/m2
Single i.v. bolus of Levoleucovorin 60 mg/m2
6R-MTHF 200 mg/m2
Single i.v. bolus of Arfolitixorin 200 mg/m2
6R-MTHF 60 mg/m2
Single i.v. bolus of Arfolitixorin 60 mg/m2

Who it enrols

Patients with operable colon cancer amenable to curative surgery, aged 18 or older, with ECOG performance status 0-1.

Endpoints

Primary

Concentration of [6R]-5,10-methylene-THF in Tumor Tissue24 hours
Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue24 hours
Concentration of [6S]-5-THF in Tumor Tissue24 hours
Concentration of [6S]-5-THF in Adjacent Mucosa Tissue24 hours
Concentration of [6S]-5-methyl-THF in Tumor Tissue24 hours

Secondary

AUC(0-2h) of [6R]-5,10-methylene-THF, [6S]-5-THF, [6S]-5-methyl-THF, [6SR]-5-formyl-THFDay 1
AUC(Last) of [6R]-5,10-methylene-THF, [6S]-5-THF, [6S]-5-methyl-THF, [6S]-5-formyl-THFDay 2
Cmax of [6R]-5,10-methylene-THF, [6S]-5-THF, [6S]-5-methyl-THF, [6S]-5-formyl-THFDay 2
Tmax of [6R]-5,10-methylene-THF, [6S]-5-THF, [6S]-5-methyl-THF, [6S]-5-formyl-THFDay 2
T(1/2) of [6R]-5,10-methylene-THF, [6S]-5-THF, [6S]-5-methyl-THF, [6S]-5-formyl-THFDay 2
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa)Day 1
Gene Expression Ratios (Mucosa:Tumor)Day 1
Homocysteine ConcentrationDay 5

Results

Not all primary endpoints met

Beyond the preview

Go deeper on NCT01681472.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01681472.