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Study of Crizotinib in Children and Adolescents With Myofibroblastic Tumors

NCT03874273 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-03-14

No results posted yet for this study

Summary

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

  • Inflammatory Myofibroblastic Tumor

Interventions

DRUG

Crizotinib

Crizotinib 280mg/m2 twice a day (for 24 months maximum)

Sponsors & Collaborators

  • Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-02-01
Completion
2021-03-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874273 on ClinicalTrials.gov