Clinical trial · Interventional
Study of Crizotinib in Children and Adolescents With Myofibroblastic Tumors
Targeted Therapy in Children and Adolescents With Recurrent, Progressive and Unresectable Inflammatory Myofibroblastic Tumor With the Inhibitor of Tyrosine Kinase -Crizotinib
- 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)
Targeted therapy based on target identification by genetic examinations is a promising direction in the treatment of patients with a complicated course of inflammatory myofibroblastic tumor. Recently, the main work covered in foreign publications, aimed at finding additional methods of treatment, by identifying new targets for targeted therapy in patients with unresectable IMT, but currently there is no standardized approach to the treatment of IMT in children worldwide. This study can show the benefits of the usage of crizotinib as targeted therapy in children with ALK/ROS1 positive unresectable, progressive or reccurent inflammatory myofibroblastic tumors. The main hypothesis is that crizotinib would increase an objective response rate in this group of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Myofibroblastic Tumor | Inflammatory Myofibroblastic Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crizotinib | Drug | Crizotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- crizotinib +
- description
- Patients with unresectable, relapsed or refractory inflammatory myofibroblastic tumor, receiving crizotinib
- interventionNames
- Drug: Crizotinib
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 2 months
- description
- The frequency of response to therapy with Crizotinib in patients with translocation of the ALK / ROS1 genes and their partners.
Secondary outcomes (2)
- measure
- Relapse-free survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 0 - 18 years * The presence of a histologically verified diagnosis of Inflammatoru Myofibroblastic Tumor, confirmed in the pathology laboratory of Dmitry Rogachev National Research Center * The presence of ttumor masses according to CT or MRI at the time of inclusion in the protocol * Unresectable or metastatic tumor * Relapse or progressive disease * Good perfomance status * Normal function of bone marrow * Normal function of a liver * Normal levels of creatinine and urea in blood * Nornal heart funсtion (LVEF \> 60%) * Clear expression of rearranged ALK/ROS1 genes * Signed Informed Consent Exclusion Criteria: * Age \>18 years * Refusal of signing the form of the informed consent * The presence of comorbidities, which may endanger patient safety * No rearrangements of ALK/ROS genes * No signs of existing tumor, according to CT and MRI
References
Publications (0)
Data not yet available