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

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ClinicalTrials.gov Identifier: NCT01681472
Recruitment Status : Completed
First Posted : September 10, 2012
Results First Posted : July 17, 2015
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Isofol Medical AB

Brief Summary:
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 or disease Intervention/treatment Phase
Colonic Neoplasms Drug: [6R] 5,10-methylenetetrahydrofolate Drug: Levoleucovorin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Comparison of Folate Concentration in Tumor Tissue and Adjacent Mucosa Between Treatment Arms. [ Time Frame: Sample taken Day 1 (Day of surgery). ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Isofol Medical AB
ClinicalTrials.gov Identifier: NCT01681472     History of Changes
Other Study ID Numbers: ISO-CC-002
2012-000522-22 ( EudraCT Number )
First Posted: September 10, 2012    Key Record Dates
Results First Posted: July 17, 2015
Last Update Posted: May 23, 2016
Last Verified: April 2016

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