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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Levoleucovorin 200 mg/m2 Levoleucovorin: i.v. bolus injection
Levoleucovorin 60 mg/m2 Levoleucovorin: i.v. bolus injection
6R-MTHF 200 mg/m2 [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
6R-MTHF 60 mg/m2 [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection

Participant Flow:   Overall Study
    Levoleucovorin 200 mg/m2   Levoleucovorin 60 mg/m2   6R-MTHF 200 mg/m2   6R-MTHF 60 mg/m2
STARTED   8   8   8   8 
COMPLETED   8   7   8   8 
NOT COMPLETED   0   1   0   0 
Adverse Event                0                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Levoleucovorin 200 mg/m2 Levoleucovorin: i.v. bolus injection
Levoleucovorin 60 mg/m2 Levoleucovorin: i.v. bolus injection
6R-MTHF 200 mg/m2 [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
6R-MTHF 60 mg/m2 [6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
Total Total of all reporting groups

Baseline Measures
   Levoleucovorin 200 mg/m2   Levoleucovorin 60 mg/m2   6R-MTHF 200 mg/m2   6R-MTHF 60 mg/m2   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   8   8   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 80.5  (9.15)   66.71  (16.89)   72  (15)   71.75  (11.25)   72.74  (13.07) 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   0   3   2   2   7 
>=65 years   8   5   6   6   25 
Gender 
[Units: Participants]
         
Female   4   5   3   4   16 
Male   4   3   5   4   16 
Region of Enrollment 
[Units: Participants]
         
Sweden   8   8   8   8   32 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Anders Rabbe
Organization: Isofol Medical
phone: +46 (0)707 64 65 00
e-mail: anders.rabbe@isofolmedical.com



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