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Clinical Trials/EUCTR2013-001280-23-SE
EUCTR2013-001280-23-SE
Active, not recruiting
Phase 1

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 - Investigation of Modufolin® as rescue therapy for osteosarcoma patients treated with HDMTX

Isofol Medical AB0 sites18 target enrollmentJuly 9, 2013
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DrugsCalciumfolinate TEVA

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Isofol Medical AB
Enrollment
18
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 9, 2013
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients must have histological evidence of osteosarcoma including metastatic osteosarcoma.
  • •2\.Patients must be eligible for high\-dose methotrexate treatment (HDMTX) according to the MAP treatment schedule described in the study protocol (see Appendix 1\) and fulfill all of the criteria below prior to first course of HDMTX in the study.
  • •a.Serum MTX: \= 0\.1µmol/L
  • •b.Neutrophils: \= 0\.25 x 109/L
  • •c.Platelets: \= 50 x 109/L
  • •d.Serum bilirubin: \= 1\.25 x ULN
  • •e.GFR \= 70 mL/min/1\.73 m2
  • •f.No AE Grade 2 or more (NCI CTCAE v4\.0\) related to HDMTX hindering a potential HDMTX administration, at the discretion of the investigator.
  • •3\.Patients must be enrolled in HDMTX course 1, 3 or 5 of the MAP treatment schedule (see Appendix 1\).
  • •4\.Patients enrolled in HDMTX course 3 or 5 must have a history of successful advancement from first to second HDMTX course within the previous MAP cycle, i.e. fulfilling all of the following criteria 8 days after start of first HDMTX course within the same MAP cycle:

Exclusion Criteria

  • •1\.Involvement in another clinical trial within 30 days before enrolment in the study.
  • •2\.Hypersensitivity to Calcium Folinate.
  • •3\.Previous treatment with glucarpidase.
  • •4\.Known serious concomitant systemic disorders (e.g., active infection including HIV, liver dysfunction, cardiac disease) that, in the opinion of the investigator, would compromise the patient's ability to complete the study

Outcomes

Primary Outcomes

Not specified

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