NCT01681472View on ClinicalTrials.gov

PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL

Enrollment

32

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions

Colonic Neoplasms

Interventions

DRUG

6R-MTHF (arfolitixorin) 200 mg/m2

i.v. bolus injection

DRUG

Levoleucovorin 200 mg/m2

i.v. bolus injection

DRUG

6R-MTHF (arfolitixorin) 60 mg/m2

i.v. bolus injection

DRUG

Levoleucovorin 60 mg/m2

i.v. bolus injection

Trial Locations (1)

461 85

Sahlgrenska University Hospital, Gothenburg

Sponsors

Lead Sponsor

Isofol Medical AB

All Listed Sponsors

lead

Isofol Medical AB

INDUSTRY