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

NCT01681472 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-09-25

Study results available
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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).

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

Sponsors & Collaborators

  • Isofol Medical AB

    lead INDUSTRY

Principal Investigators

  • Kristoffer Derwinger, MD PhD · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01681472 on ClinicalTrials.gov