Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Isofol Medical AB
ClinicalTrials.gov Identifier:
NCT01681472
First received: September 5, 2012
Last updated: April 20, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to compare the concentration of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®) respectively (60 and 200 mg/m2).

Condition Intervention Phase
Colonic Neoplasms
Drug: [6R] 5,10-methylenetetrahydrofolate
Drug: Levoleucovorin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Single-Blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® (60 or 200 mg/m2) Compared to Levoleucovorin (60 or 200 mg/m2) in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer

Resource links provided by NLM:


Further study details as provided by Isofol Medical AB:

Primary Outcome Measures:
  • Comparison of Folate Concentration in Tumor Tissue and Adjacent Mucosa Between Treatment Arms. [ Time Frame: Sample taken Day 1 (Day of surgery). ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levoleucovorin 200 mg/m2 Drug: Levoleucovorin
i.v. bolus injection
Other Name: Isovorin®
Active Comparator: Levoleucovorin 60 mg/m2 Drug: Levoleucovorin
i.v. bolus injection
Other Name: Isovorin®
Experimental: 6R-MTHF 200 mg/m2 Drug: [6R] 5,10-methylenetetrahydrofolate
i.v. bolus injection
Other Names:
  • Modufolin®
  • 6R-MTHF
  • ISO-901
Experimental: 6R-MTHF 60 mg/m2 Drug: [6R] 5,10-methylenetetrahydrofolate
i.v. bolus injection
Other Names:
  • Modufolin®
  • 6R-MTHF
  • ISO-901

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have operable colon cancer that is amenable to curative surgery.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681472

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 461 85
Sponsors and Collaborators
Isofol Medical AB
Investigators
Principal Investigator: Kristoffer Derwinger, MD PhD Sahlgrenska University Hospital, Sweden
  More Information

Responsible Party: Isofol Medical AB
ClinicalTrials.gov Identifier: NCT01681472     History of Changes
Other Study ID Numbers: ISO-CC-002  2012-000522-22 
Study First Received: September 5, 2012
Results First Received: May 21, 2015
Last Updated: April 20, 2016
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency
Sweden: Swedish Data Inspection Board

Keywords provided by Isofol Medical AB:
Colon cancer
5,10-methylenetetrahydrofolate
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Therapeutic Uses
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Levoleucovorin
Leucovorin
Tetrahydrofolates
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 28, 2016