Colonic NeoplasmsPhase 1/2NCT01681472
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
A Phase 1/2 study testing 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2 and 6R-MTHF (arfolitixorin) 60 mg/m2 in people with Colonic Neoplasms, run by Isofol Medical AB at 1 site in Sweden.
Trial summary
The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2 and 6R-MTHF (arfolitixorin) 60 mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Aug 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Operable colon cancer amenable to curative surgery.
- Performance status of 0 to 1
- Informed consent form
- Patients must be at least 18 years of age.
Main Exclusion Criteria:
- Any concurrent other anti-tumor therapy
- Any prohibited concomitant medication within 30 days of surgery
- Pregnancy or breast-feeding.
- Second primary malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® (60 or 200mg/m2) Compared to Levoleucovorin (60 or 200mg/m2) in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer
The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).
Read the detailed description
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).
- Conditions
- Colonic Neoplasms
- Being tested
- 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2, 6R-MTHF (arfolitixorin) 60 mg/m2, Levoleucovorin 60 mg/m2
- Keywords
- Colon cancer, 5,10-methylenetetrahydrofolate, Rectal Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Therapeutic Uses, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6R-MTHF (arfolitixorin) 200 mg/m2Drug
Also called Modufolin®, ISO-901, [6R] 5,10-methylenetetrahydrofolate, arfolitixorin
i.v. bolus injection
Levoleucovorin 200 mg/m2Drug
Also called Isovorin®
i.v. bolus injection
6R-MTHF (arfolitixorin) 60 mg/m2Drug
Also called Modufolin®, ISO-901, [6R] 5,10-methylenetetrahydrofolate, arfolitixorin
i.v. bolus injection
Levoleucovorin 60 mg/m2Drug
Also called Isovorin®
i.v. bolus injection
| Study group | Role | What they receive |
|---|---|---|
| Levoleucovorin 200 mg/m2 | Active comparator | One i.v. bolus injection of study drug after the patient has been anaesthetized. Receives: Drug: Levoleucovorin 200 mg/m2 |
| Levoleucovorin 60 mg/m2 | Active comparator | One i.v. bolus injection of study drug after the patient has been anaesthetized. Receives: Drug: Levoleucovorin 60 mg/m2 |
| 6R-MTHF 200 mg/m2 | Experimental | One i.v. bolus injection of study drug after the patient has been anaesthetized. Receives: Drug: 6R-MTHF (arfolitixorin) 200 mg/m2 |
| 6R-MTHF 60 mg/m2 | Experimental | One i.v. bolus injection of study drug after the patient has been anaesthetized. Receives: Drug: 6R-MTHF (arfolitixorin) 60 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of [6R]-5,10-methylene-THF in Tumor Tissue
Comparison of concentration of the active substance in Modufolin: [6R]-5,10-methylene-THF in tumor tissue after the different treatments.
Measured: 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
Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue
Comparison of concentration of the active substance in Modufolin: [6R]-5,10-methylene-THF in mucosa adjacent to the tumor after the different treatments.
Measured: 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
Concentration of [6S]-5-THF in Tumor Tissue
Comparison of concentration of the metabolite [6S]-5-THF in tumor after the different treatments.
Measured: 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
Concentration of [6S]-5-THF in Adjacent Mucosa Tissue
Comparison of concentration of the metabolite [6S]-5-THF in mucosa adjacent to the tumor after the different treatments.
Measured: 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
Concentration of [6S]-5-methyl-THF in Tumor Tissue
Comparison of concentration of the metabolite [6S]-5-methyl-THF in tumor after the different treatments.
Measured: 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
Concentration of [6S]-5-methyl-THF in Adjacent Mucosa Tissue
Comparison of concentration of the metabolite [6S]-5-methyl-THF in mucosa adjacent to the tumor after the different treatments.
Measured: 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
Concentration of [6S]-5-formyl-THF in Tumor Tissue
Comparison of concentration of the metabolite [6S]-5-formyl-THF in tumor after the different treatments.
Measured: 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
Concentration of [6S]-5-formyl-THF in Adjacent Mucosa Tissue
Comparison of concentration of the metabolite [6S]-5-formyl-THF in mucosa adjacent to the tumor after the different treatments.
Measured: 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
Secondary outcomes (35)
AUC(0-2h) of [6R]-5,10-methylene-THF
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
Measured: Samples taken Day 1 (Day of surgery)
AUC(0-2h) of [6S]-5-THF
Area under the plasma concentration versus time curve from time 0 to 2 hours, for the metabolite [6S]-5-THF
Measured: Samples taken Day 1 (Day of surgery)
AUC(0-2h) of [6S]-5-methyl-THF
Area under the plasma concentration versus time curve from time 0 to 2 hours, for the metabolite: [6S]-5-methyl-THF
Measured: Samples taken Day 1 (Day of surgery)
AUC(0-2h) of [6SR]-5-formyl-THF
Area under the plasma concentration versus time curve from time 0 to 2 hours, for the metabolite [6S]-5-formyl-THF
Measured: Samples taken Day 1 (Day of surgery)
AUC(Last) of [6R]-5,10-methylene-THF
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
Measured: Samples taken Day 1 (Day of surgery) and Day 2
AUC(Last) of [6S]-5-THF
Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite [6S]-5-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
AUC(Last) of [6S]-5-methyl-THF
Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite [6S]-5-methyl-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
AUC(Last) of [6S]-5-formyl-THF
Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite [6S]-5-formyl-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6R]-5,10-methylene-THF
Maximum concentration (Cmax) in plasma of the active substance in Modufolin: [6R]-5,10-methylene-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6S]-5-THF in Plasma
Maximum concentration (Cmax) in plasma of the metabolite [6S]-5-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6S]-5-methyl-THF in Plasma
Maximum concentration (Cmax) in plasma of the metabolite [6S]-5-methyl-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6S]-5-formyl-THF in Plasma
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
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6R]-5,10-methylene-THF
Timepoint (tmax) when Cmax in plasma occurs of the active substance in Modufolin: [6R]-5,10-methylene-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6S]-5-THF
Timepoint (tmax) when Cmax in plasma occurs for the metabolite [6S]-5-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6S]-5-methyl-THF
Timepoint (tmax) when Cmax in plasma occurs for the metabolite [6S]-5-methyl-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6S]-5-formyl-THF
Timepoint (tmax) when Cmax in plasma occurs for the metabolite [6S]-5-formyl-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6R]-5,10-methylene-THF
Terminal plasma elimination half-life time for the active substance in Modufolin: [6R]-5,10-methylene-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6S]-5-THF
Terminal plasma elimination half-life time for the metabolite [6S]-5-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6S]-5-methyl-THF
Terminal plasma elimination half-life time for the metabolite [6S]-5-methyl-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6S]-5-formyl-THF
Terminal plasma elimination half-life time for the metabolite [6S]-5-formyl-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6R]-5,10-methylene-THF
The time-point for the last measurable concentration of the active substance in Modufolin: [6R]-5,10-methylene-THF
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6S]-5-THF
The time-point for the last measurable concentration for the metabolite [6S]-5-TH in plasma
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6S]-5-methyl-THF
The time-point for the last measurable concentration for the metabolite [6S]-5-methyl-THF in plasma
Measured: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6S]-5-formyl-THF
The time-point for the last measurable concentration for the metabolite [6S]-5-formyl-THF in plasma
Measured: Samples taken Day 1 (Day of surgery) and Day 2
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6R]-5,10-methylene-THF
Correlation between the exposure of [6R]-5,10-methylene-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6R]-5,10-methylene-THF in the tumor or adjacent mucosa at surgery.
Measured: Samples taken Day 1 (Day of surgery)
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-THF
Correlation between the exposure of [6S]-5-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6S]-5-THF in the tumor or adjacent mucosa at surgery.
Measured: Samples taken Day 1 (Day of surgery)
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-methyl-THF
Correlation between the exposure of [6S]-5-methyl-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6S]-5-methyl-THF in the tumor or adjacent mucosa at surgery.
Measured: Samples taken Day 1 (Day of surgery)
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-formyl-THF
Correlation between the exposure of [6S]-5-formyl-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6S]-5-formyl-THF in the tumor or adjacent mucosa at surgery.
Measured: Samples taken Day 1 (Day of surgery)
Gene Expression Ratios (Mucosa:Tumor)
Concentration of different genes involved in folate transport and metabolism were analysed in both tumor and adjacent mucosa. The concentration in mucosa was divided by the concentration in tumor. A value above 1 indicate that the gene expression was higher in mucosa than in tumor and a value below 1 that the gene expression was higher in tumor than in mucosa.
Measured: Sample taken Day 1 (Day of Surgery)
Correlation of Gene Expression in Tumor and Adjacent Mucosa
Concentration of the gene expression was analysed in both tumor and adjacent mucosa. The presence of any correlation between the results (i.e., concentration of the gene expression in tumor versus adjacent mucosa) was evaluated for each treatment. No evaluation was done between treatments.
Measured: Sample taken Day 1 (Day of Surgery)
Homocystein Concentration
Blood samples for folate biomarker (homocystein) analysis were collected at Screening, Day 2, and Day 5 (End of study visit).
Measured: Samples taken at Screening visit, Day 2, and End of Study (Day 5)
S-Folate Concentration
Blood samples for folate biomarker (S-folate) analysis were collected at Screening, Day 2 and Day 5 (End of study visit).
Measured: Samples taken at Screening visit, Day 2 and End of Study (Day 5)
Change in Homocystein Concentration From Screening
Blood samples for folate biomarker (homocystein) analysis were collected at Screening, Day 2 and Day 5 (End of study visit). Changes from screening to later visits were counted.
The criteria for assessment categories "normal", "low" and "high" were based on the reference ranges for plasma-Homocystein as follows: "low" <4,7 mcmol/L; "normal" => 4,7 and <=16 mcmol/L; "high" >16 mcmol/L. Values were applicable for both male and female adults.
Measured: Samples taken at Screening visit, Day 2 and End of Study (Day 5)
Change in S-Folate Concentration From Screening
Blood samples for folate biomarker (S-folate) analysis were collected at Screening, Day 2 and Day 5 (End of study visit). Changes from screening to later visits were counted.
Measured: Samples taken at Screening visit, Day 2 and End of Study (Day 5)
Number of AEs Per Severity
Number of reported AEs per treatment with respect to severity
Measured: Screening visit until end of study, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isofol Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristoffer Derwinger, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681472
- Sponsor's protocol ID
- ISO-CC-002
- Other IDs
- 2012-000522-22
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2012
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® (60 or 200mg/m2) Compared to Levoleucovorin (60 or 200mg/m2) in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer
- ClinicalTrials.gov ID
- NCT01681472
- Acronym / sponsor ID
- ISO-CC-002
- Conditions
- Colonic Neoplasms
- Keywords
- Colon cancer, 5,10-methylenetetrahydrofolate, Rectal Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Isofol Medical ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Posted 17 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Levoleucovorin 200 mg/m2 | Active comparator | Drug: Levoleucovorin 200 mg/m2One i.v. bolus injection of study drug after the patient has been anaesthetized. |
| Levoleucovorin 60 mg/m2 | Active comparator | Drug: Levoleucovorin 60 mg/m2One i.v. bolus injection of study drug after the patient has been anaesthetized. |
| 6R-MTHF 200 mg/m2 | Experimental | Drug: 6R-MTHF (arfolitixorin) 200 mg/m2One i.v. bolus injection of study drug after the patient has been anaesthetized. |
| 6R-MTHF 60 mg/m2 | Experimental | Drug: 6R-MTHF (arfolitixorin) 60 mg/m2One i.v. bolus injection of study drug after the patient has been anaesthetized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6R-MTHF (arfolitixorin) 200 mg/m2Also: Modufolin®, ISO-901, [6R] 5,10-methylenetetrahydrofolate, arfolitixorini.v. bolus injection | Drug | 6R-MTHF 200 mg/m2 |
| Levoleucovorin 200 mg/m2Also: Isovorin®i.v. bolus injection | Drug | Levoleucovorin 200 mg/m2 |
| 6R-MTHF (arfolitixorin) 60 mg/m2Also: Modufolin®, ISO-901, [6R] 5,10-methylenetetrahydrofolate, arfolitixorini.v. bolus injection | Drug | 6R-MTHF 60 mg/m2 |
| Levoleucovorin 60 mg/m2Also: Isovorin®i.v. bolus injection | Drug | Levoleucovorin 60 mg/m2 |
Primary outcome
Concentration of [6R]-5,10-methylene-THF in Tumor Tissue
Time frame: 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.
Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue
Time frame: 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.
Concentration of [6S]-5-THF in Tumor Tissue
Time frame: 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.
Concentration of [6S]-5-THF in Adjacent Mucosa Tissue
Time frame: 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.
Concentration of [6S]-5-methyl-THF in Tumor Tissue
Time frame: 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.
Concentration of [6S]-5-methyl-THF in Adjacent Mucosa Tissue
Time frame: 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.
Concentration of [6S]-5-formyl-THF in Tumor Tissue
Time frame: 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.
Concentration of [6S]-5-formyl-THF in Adjacent Mucosa Tissue
Time frame: 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.
35 secondary outcomes
AUC(0-2h) of [6R]-5,10-methylene-THF
Time frame: Samples taken Day 1 (Day of surgery)
AUC(0-2h) of [6S]-5-THF
Time frame: Samples taken Day 1 (Day of surgery)
AUC(0-2h) of [6S]-5-methyl-THF
Time frame: Samples taken Day 1 (Day of surgery)
AUC(0-2h) of [6SR]-5-formyl-THF
Time frame: Samples taken Day 1 (Day of surgery)
AUC(Last) of [6R]-5,10-methylene-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
AUC(Last) of [6S]-5-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
AUC(Last) of [6S]-5-methyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
AUC(Last) of [6S]-5-formyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6R]-5,10-methylene-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6S]-5-THF in Plasma
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6S]-5-methyl-THF in Plasma
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Cmax of [6S]-5-formyl-THF in Plasma
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6R]-5,10-methylene-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6S]-5-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6S]-5-methyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Tmax of [6S]-5-formyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6R]-5,10-methylene-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6S]-5-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6S]-5-methyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(1/2) of [6S]-5-formyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6R]-5,10-methylene-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6S]-5-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6S]-5-methyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
T(Last) of [6S]-5-formyl-THF
Time frame: Samples taken Day 1 (Day of surgery) and Day 2
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6R]-5,10-methylene-THF
Time frame: Samples taken Day 1 (Day of surgery)
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-THF
Time frame: Samples taken Day 1 (Day of surgery)
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-methyl-THF
Time frame: Samples taken Day 1 (Day of surgery)
Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-formyl-THF
Time frame: Samples taken Day 1 (Day of surgery)
Gene Expression Ratios (Mucosa:Tumor)
Time frame: Sample taken Day 1 (Day of Surgery)
Correlation of Gene Expression in Tumor and Adjacent Mucosa
Time frame: Sample taken Day 1 (Day of Surgery)
Homocystein Concentration
Time frame: Samples taken at Screening visit, Day 2, and End of Study (Day 5)
S-Folate Concentration
Time frame: Samples taken at Screening visit, Day 2 and End of Study (Day 5)
Change in Homocystein Concentration From Screening
Time frame: Samples taken at Screening visit, Day 2 and End of Study (Day 5)
Change in S-Folate Concentration From Screening
Time frame: Samples taken at Screening visit, Day 2 and End of Study (Day 5)
Number of AEs Per Severity
Time frame: Screening visit until end of study, Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristoffer Derwinger, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2 and 6R-MTHF (arfolitixorin) 60 mg/m2 in people with Colonic Neoplasms, run by Isofol Medical AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of [6R]-5,10-methylene-THF in Tumor Tissue (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.