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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Colonic Neoplasms
Interventions Drug: [6R] 5,10-methylenetetrahydrofolate
Drug: Levoleucovorin
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levoleucovorin 200 mg/m2 Levoleucovorin 60 mg/m2 6R-MTHF 200 mg/m2 6R-MTHF 60 mg/m2
Hide Arm/Group Description Levoleucovorin: i.v. bolus injection Levoleucovorin: i.v. bolus injection [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
Period Title: Overall Study
Started 8 8 8 8
Completed 8 7 8 8
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Arm/Group Title Levoleucovorin 200 mg/m2 Levoleucovorin 60 mg/m2 6R-MTHF 200 mg/m2 6R-MTHF 60 mg/m2 Total
Hide Arm/Group Description Levoleucovorin: i.v. bolus injection Levoleucovorin: i.v. bolus injection [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
80.5  (9.15) 66.71  (16.89) 72  (15) 71.75  (11.25) 72.74  (13.07)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
3
  37.5%
2
  25.0%
2
  25.0%
7
  21.9%
>=65 years
8
 100.0%
5
  62.5%
6
  75.0%
6
  75.0%
25
  78.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
Female
4
  50.0%
5
  62.5%
3
  37.5%
4
  50.0%
16
  50.0%
Male
4
  50.0%
3
  37.5%
5
  62.5%
4
  50.0%
16
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 8 participants 8 participants 8 participants 8 participants 32 participants
8 8 8 8 32
1.Primary Outcome
Title Comparison of Folate Concentration in Tumor Tissue and Adjacent Mucosa Between Treatment Arms.
Hide Description [Not Specified]
Time Frame Sample taken Day 1 (Day of surgery).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.
Arm/Group Title Levoleucovorin 200 mg/m2 Levoleucovorin 60 mg/m2 6R-MTHF 200 mg/m2 6R-MTHF 60 mg/m2
Hide Arm/Group Description:
Levoleucovorin: i.v. bolus injection
Levoleucovorin: i.v. bolus injection
[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
Overall Number of Participants Analyzed 8 6 8 7
Mean (Standard Deviation)
Unit of Measure: pmol/g
tumor tissue (6R)-5,10-methylene-THF 1871  (1159) 959  (417) 4725  (2210) 2393  (1920)
adjacent mucosa (6R)-5,10-methylene-THF 1333  (852) 626  (439) 5099  (3927) 3481  (3926)
tumor tissue (6S)-5-methy-THF 3574  (2415) 1904  (918) 4396  (1858) 1882  (1204)
adjacent mucosa (6S)-5-methy-THF 3667  (2043) 1216  (455) 2494  (765) 2066  (1517)
tumor tissue (6S)-5-THF 1329  (720) 933  (598) 4175  (3127) 2219  (1995)
adjacent mucosa (6S)-5-THF 1333  (852) 626  (439) 5099  (3927) 3481  (3926)
tumor tissue (6S)-5-formyl-THF 3611  (3899) 512  (259) 100  (47) 57  (48)
adjacent mucosa (6S)-5-formyl-THF 5456  (3963) 1403  (640) 82  (77) 42  (18)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levoleucovorin 200 mg/m2 Levoleucovorin 60 mg/m2 6R-MTHF 200 mg/m2 6R-MTHF 60 mg/m2
Hide Arm/Group Description Levoleucovorin: i.v. bolus injection Levoleucovorin: i.v. bolus injection [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
All-Cause Mortality
Levoleucovorin 200 mg/m2 Levoleucovorin 60 mg/m2 6R-MTHF 200 mg/m2 6R-MTHF 60 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levoleucovorin 200 mg/m2 Levoleucovorin 60 mg/m2 6R-MTHF 200 mg/m2 6R-MTHF 60 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      1/7 (14.29%)      2/8 (25.00%)      2/8 (25.00%)    
Cardiac disorders         
Acute mycardial infarction  0/8 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Cardiac arrest  0/8 (0.00%)  1/7 (14.29%)  0/8 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications         
Postoperative wound complication  0/8 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Anastomotic leak  0/8 (0.00%)  0/7 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  0/8 (0.00%)  0/7 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levoleucovorin 200 mg/m2 Levoleucovorin 60 mg/m2 6R-MTHF 200 mg/m2 6R-MTHF 60 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/8 (50.00%)      2/7 (28.57%)      4/8 (50.00%)      5/8 (62.50%)    
Cardiac disorders         
Atrial fibrillation  2/8 (25.00%)  2 0/7 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0
Gastrointestinal disorders         
Dyspepsia  0/8 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  2
Vomiting  0/8 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1
Nausea  0/8 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Abdominal pain  0/8 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Mouth haemorrhage  1/8 (12.50%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
General disorders         
Pyrexia  0/8 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Infections and infestations         
Pneumonia  0/8 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1
Injury, poisoning and procedural complications         
Hepatic enzyme increased  0/8 (0.00%)  0 0/7 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Nervous system disorders         
Paralysis  0/8 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  0/8 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Dysphonia  0/8 (0.00%)  0 1/7 (14.29%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Dyspnoea  1/8 (12.50%)  1 0/7 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Vascular disorders         
Flushing  0/8 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Hypotension  0/8 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Anders Rabbe
Organization: Isofol Medical
Phone: +46 (0)707 64 65 00
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 Submitted: September 5, 2012
First Posted: September 10, 2012
Results First Submitted: May 21, 2015
Results First Posted: July 17, 2015
Last Update Posted: May 23, 2016