Trial · NCT01681472
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
NCT01681472, Phase 1, Phase 2, Completed, Isofol Medical AB; results first posted 2015-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer. Trials, record NCT01681472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01681472
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
- NCT number
- NCT01681472
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Isofol Medical AB
- Conditions
- Colonic Neoplasms
- Interventions
- 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2, 6R-MTHF (arfolitixorin) 60 mg/m2, Levoleucovorin 60 mg/m2
- First posted
- 2012-09-10
- Last updated
- 2020-09-25
- Other registries' IDs
- eudract:2012-000522-22
- Results first posted
- 2015-07-17
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Concentration of [6R]-5,10-methylene-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the active substance in Modufolin: \[6R\]-5,10-methylene-THF in tumor tissue after the different treatments. |
| Primary | Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the active substance in Modufolin: \[6R\]-5,10-methylene-THF in mucosa adjacent to the tumor after the different treatments. |
| Primary | Concentration of [6S]-5-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the metabolite \[6S\]-5-THF in tumor after the different treatments. |
| Primary | Concentration of [6S]-5-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the metabolite \[6S\]-5-THF in mucosa adjacent to the tumor after the different treatments. |
| Primary | Concentration of [6S]-5-methyl-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the metabolite \[6S\]-5-methyl-THF in tumor after the different treatments. |
| Primary | Concentration of [6S]-5-methyl-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the metabolite \[6S\]-5-methyl-THF in mucosa adjacent to the tumor after the different treatments. |
| Primary | Concentration of [6S]-5-formyl-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the metabolite \[6S\]-5-formyl-THF in tumor after the different treatments. |
| Primary | Concentration of [6S]-5-formyl-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Comparison of concentration of the metabolite \[6S\]-5-formyl-THF in mucosa adjacent to the tumor after the different treatments. |
| Secondary | AUC(0-2h) of [6R]-5,10-methylene-THF | Samples taken Day 1 (Day of surgery) | Area under the plasma concentration versus time curve from time 0 to 2 hours, for the active substance in Modufolin: \[6R\]-5,10-methylene-THF |
| Secondary | AUC(0-2h) of [6S]-5-THF | Samples taken Day 1 (Day of surgery) | Area under the plasma concentration versus time curve from time 0 to 2 hours, for the metabolite \[6S\]-5-THF |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Concentration of [6R]-5,10-methylene-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| PRIMARY | Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| PRIMARY | Concentration of [6S]-5-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| PRIMARY | Concentration of [6S]-5-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| PRIMARY | Concentration of [6S]-5-methyl-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| PRIMARY | Concentration of [6S]-5-methyl-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| PRIMARY | Concentration of [6S]-5-formyl-THF in Tumor Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| PRIMARY | Concentration of [6S]-5-formyl-THF in Adjacent Mucosa Tissue | Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | pmol/g | MEAN |
| SECONDARY | AUC(0-2h) of [6R]-5,10-methylene-THF | Samples taken Day 1 (Day of surgery) | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | mcg*h/L | MEAN |
| SECONDARY | AUC(0-2h) of [6S]-5-THF | Samples taken Day 1 (Day of surgery) | Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure. | mcg*h/L | MEAN |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group326
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Concentration of [6R]-5,10-methylene-THF in Tumor Tissue | Levoleucovorin 200 mg/m2 | 1871 | Standard Deviation 1159 | pmol/g | |
| Concentration of [6R]-5,10-methylene-THF in Tumor Tissue | Levoleucovorin 60 mg/m2 | 959 | Standard Deviation 417 | pmol/g | |
| Concentration of [6R]-5,10-methylene-THF in Tumor Tissue | Modufolin 200 mg/m2 | 4725 | Standard Deviation 2210 | pmol/g | |
| Concentration of [6R]-5,10-methylene-THF in Tumor Tissue | Modufolin 60 mg/m2 | 2393 | Standard Deviation 1920 | pmol/g | |
| Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue | Levoleucovorin 200 mg/m2 | 1333 | Standard Deviation 852 | pmol/g | |
| Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue | Levoleucovorin 60 mg/m2 | 626 | Standard Deviation 439 | pmol/g | |
| Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue | Modufolin 200 mg/m2 | 5099 | Standard Deviation 3927 | pmol/g | |
| Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue | Modufolin 60 mg/m2 | 3481 | Standard Deviation 3926 | pmol/g | |
| Concentration of [6S]-5-THF in Tumor Tissue | Levoleucovorin 200 mg/m2 | 1329 | Standard Deviation 720 | pmol/g | |
| Concentration of [6S]-5-THF in Tumor Tissue | Levoleucovorin 60 mg/m2 | 933 | Standard Deviation 598 | pmol/g |
1 to 10 of 326Source ClinicalTrials.gov
See all 326 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levoleucovorin 200 mg/m2 | 8 | |
| Overall Study | STARTED | Levoleucovorin 60 mg/m2 | 8 | |
| Overall Study | STARTED | 6R-MTHF 200 mg/m2 | 8 | |
| Overall Study | STARTED | 6R-MTHF 60 mg/m2 | 8 | |
| Overall Study | COMPLETED | Levoleucovorin 200 mg/m2 | 8 | |
| Overall Study | COMPLETED | Levoleucovorin 60 mg/m2 | 7 | |
| Overall Study | COMPLETED | 6R-MTHF 200 mg/m2 | 8 | |
| Overall Study | COMPLETED | 6R-MTHF 60 mg/m2 | 8 | |
| Overall Study | NOT COMPLETED | Levoleucovorin 200 mg/m2 | 0 | |
| Overall Study | NOT COMPLETED | Levoleucovorin 60 mg/m2 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pneumonia | Infections and infestations | Levoleucovorin 200 mg/m2 | 0 | 8 | 0 |
| other | Pneumonia | Infections and infestations | Levoleucovorin 60 mg/m2 | 0 | 7 | 0 |
| other | Pneumonia | Infections and infestations | 6R-MTHF 200 mg/m2 | 1 | 8 | 1 |
| other | Pneumonia | Infections and infestations | 6R-MTHF 60 mg/m2 | 1 | 8 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Levoleucovorin 200 mg/m2 | 0 | 8 | 0 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Levoleucovorin 60 mg/m2 | 0 | 7 | 0 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 6R-MTHF 200 mg/m2 | 0 | 8 | 0 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 6R-MTHF 60 mg/m2 | 1 | 8 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Levoleucovorin 200 mg/m2 | 0 | 8 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Levoleucovorin 60 mg/m2 | 0 | 7 | 0 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levoleucovorin 200 mg/m2 | ||
| Total, all-cause mortality | Levoleucovorin 60 mg/m2 | ||
| Total, all-cause mortality | 6R-MTHF 200 mg/m2 | ||
| Total, all-cause mortality | 6R-MTHF 60 mg/m2 | ||
| Total, other adverse events | Levoleucovorin 200 mg/m2 | 4 | 8 |
| Total, other adverse events | Levoleucovorin 60 mg/m2 | 2 | 7 |
| Total, other adverse events | 6R-MTHF 200 mg/m2 | 4 | 8 |
| Total, other adverse events | 6R-MTHF 60 mg/m2 | 5 | 8 |
| Total, serious adverse events | Levoleucovorin 200 mg/m2 | 0 | 8 |
| Total, serious adverse events | Levoleucovorin 60 mg/m2 | 1 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01681472
GET https://conductscience.org/api/trials/v1/NCT01681472/registered?page=2