At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 18 enrolled

Drug / intervention

Calcium Folinate +1 moredrug

Likely dose

Calcium Folinate 15 mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01987102

NCT01987102Phase 2Completed

Compare CT.gov

An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the Modufolin® Dose With Most Favorable Safety Prospect and Confirmed Ability to Mitigate High-Dose Methotrexate Induced Toxicity During Treatment of Osteosarcoma Patients

Isofol Medical AB·interventional·Posted Nov 19, 2013·Updated Sep 25, 2020

In Brief

A Phase 2 clinical trial evaluating Calcium Folinate and [6R] 5,10-methylenetetrahydrofolate (arfolitixorin) for Osteosarcoma. Completed, enrolled 18 participants across 5 sites in 4 countries.

Detailed Summary

An open-label, multicenter, phase I/II clinical trial to identify the \[6R\] 5,10-methylenetetrahydrofolate (arfolitixorin) dose with most favorable safety prospect and confirmed ability to mitigate high-dose methotrexate induced toxicity during treatment of osteosarcoma patients

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOsteosarcoma

CountriesCzechia, Hungary, Poland, Sweden

Collaborators--

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedNov 2013

Enrollment StartDec 2013

Primary CompletionJan 2017

TodayJul 2026

First PostedNov 19, 2013

Enrollment StartDec 1, 2013

Primary CompletionJan 3, 2017

TodayJul 2, 2026

Enrollment to primary: 3.1 yearsPosted 12.6 years ago

Interventions

Calcium Folinatedrug

The enrolled patients will be treated according to the MAP schedule and will receive the study drug Calcium Folinate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations. All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and \[6R\] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) \[6R\] 5,10-methylenetetrahydrofolate dose cohort groups: with \[6R\] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort.

[6R] 5,10-methylenetetrahydrofolate (arfolitixorin)drug

The enrolled patients will be treated according to the MAP schedule and will receive the study drug \[6R\] 5,10-methylenetetrahydrofolate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations. All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and \[6R\] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) \[6R\] 5,10-methylenetetrahydrofolate® dose cohort groups: with \[6R\] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort.