Trial · NCT01681472
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 43
Download this page as JSON| 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 |
| Secondary | AUC(0-2h) of [6S]-5-methyl-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-methyl-THF |
| Secondary | AUC(0-2h) of [6SR]-5-formyl-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-formyl-THF |
| Secondary | AUC(Last) of [6R]-5,10-methylene-THF | Samples taken Day 1 (Day of surgery) and Day 2 | Area under the plasma concentration versus time curve, from time 0 to the last time point, for the active substance in Modufolin: \[6R\]-5,10-methylene-THF |
| Secondary | AUC(Last) of [6S]-5-THF | Samples taken Day 1 (Day of surgery) and Day 2 | Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite \[6S\]-5-THF |
| Secondary | AUC(Last) of [6S]-5-methyl-THF | Samples taken Day 1 (Day of surgery) and Day 2 | Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite \[6S\]-5-methyl-THF |
| Secondary | AUC(Last) of [6S]-5-formyl-THF | Samples taken Day 1 (Day of surgery) and Day 2 | Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite \[6S\]-5-formyl-THF |
| Secondary | Cmax of [6R]-5,10-methylene-THF | Samples taken Day 1 (Day of surgery) and Day 2 | Maximum concentration (Cmax) in plasma of the active substance in Modufolin: \[6R\]-5,10-methylene-THF |
| Secondary | Cmax of [6S]-5-THF in Plasma | Samples taken Day 1 (Day of surgery) and Day 2 | Maximum concentration (Cmax) in plasma of the metabolite \[6S\]-5-THF |
| Secondary | Cmax of [6S]-5-methyl-THF in Plasma | Samples taken Day 1 (Day of surgery) and Day 2 | Maximum concentration (Cmax) in plasma of the metabolite \[6S\]-5-methyl-THF |
| Secondary | Cmax of [6S]-5-formyl-THF in Plasma | Samples taken Day 1 (Day of surgery) and Day 2 | Maximum concentration (Cmax) in plasma of the active substance in Modufolin: \[6R\] 5,10- methylene-THF and the metabolites: \[6S\]-5-THF, \[6S\]-5-methyl-THF, and \[6S\]-5-formyl-THF |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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