Clinical trial · Interventional
Protective Effect of Mangafodipir Against Oxaliplatin Neurotoxicity
Evaluation of Mangafodipir Protective Activity Against Oxaliplatin Neurotoxicity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oxaliplatin is a major antitumor agent but its use is limited by potentially disabling neurotoxicity, characterized by a sensitive defect in the extremities.Mangafodipir is a MRI contrast agent with antioxidant properties. Our previous laboratory works showed that mangafodipir is able to prevent hematologic toxicity of several chemotherapy agents, including oxaliplatin and to increase their antitumor activity. Preliminary clinical data suggested that mangafodipir could prevent oxaliplatin neurotoxicity.The primary purpose of the present study is to assess the protective effect of mangafodipir in patients who have a already moderate oxaliplatin neuropathy and in whom the continuation of this treatment is desirable because of significant antitumor effect.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neurotoxic Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mangafodipir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Mangafodipir
Primary outcomes (1)
- measure
- Maximal neuropathy severity (NCI-CTC score) established before each oxaliplatin injection
- timeFrame
- every 15 days
Secondary outcomes (2)
- measure
- Number of oxaliplatin administration
- timeFrame
- every 15 days
- measure
- Progression free survival (time from inclusion to cancer progression)
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * NCI CTC grade 2 or more neuropathy induced by oxaliplatine * At least 18 years old * ECOG PS: 2 or less * Life expectancy longer than 3 months * Written informed consent * Adequate hematologic, liver and renal functions Exclusion Criteria: * Known hypersensibility to oxaliplatine * Cancer resistant to oxaliplatine * Fertile woman or man not willing to use adequate contraception * Pregnant or lactating women * Vitamin B6 administration within 48h prior to mangafodipir administration * Uncontrolled infection * Treatment with any other investigational agent, or participation in another clinical trial within 3 weeks prior to first administration of mangafodipir * Evidence of any other disease or condition that contra-indicates the use of an investigational drug * No Social Security insurance
References
Publications (1)
- RESULTCoriat R, Alexandre J, Nicco C, Quinquis L, Benoit E, Chereau C, Lemarechal H, Mir O, Borderie D, Treluyer JM, Weill B, Coste J, Goldwasser F, Batteux F. Treatment of oxaliplatin-induced peripheral neuropathy by intravenous mangafodipir. J Clin Invest. 2014 Jan;124(1):262-72. doi: 10.1172/JCI68730. Epub 2013 Dec 20. PMID 24355920