A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignanciesStudy ITCC 053 - CRISP

Erasmus Medical Center0 sites82 target enrollmentMay 23, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Children and young adults with malignancies carrying a genetic alteration of ALK, MET or ROS1 with no better treatment options according to the current (inter)national guidelines
Sponsor: Erasmus Medical Center
Enrollment: 82
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

May 23, 2017

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Histologically confirmed diagnosis of other solid tumor or lymphomas (including ALCL) that is relapsed or refractory to standard therapy, or patients with newly diagnosed IMT for whom surgery may not be feasible for close proximity to vital structures, without prior tumor\-shrinkage and no other feasible options are available as per local standard of care.
•Age at enrolment \=1 year of age and \= 21 years.
•Lansky play score \> 60%; or Karnofsky performance status \> 60%.
•Target gene aberration as defined as:
•o A point mutation in the kinase domain of ALK that results in an amino\-acid change, and is not a known polymorphism.
•o An amplification of the ALK gene, defined as \= 9 copies per cell, or 4 copies per haploid genome. When assessed by FISH, ALK amplification must be observed in focal clusters of tumor cells (not only single cells) or in more than one\-third of the tumor cells.
•o A rearrangement in \>15% of the tumor cells (by break apart FISH\-assay or RNAseq).
•o A ROS1 rearrangement in \> 15% of the tumor cells (by break apart FISH\- assay or RNAseq).
•o An amplification of the MET\-gene, defined as of \=5 MET signals per tumor cell (by break apart FISH).
•o A MET mutation, defined as the presence of a somatic mutation (Direct, bi\- directional sequencing of exon 16\-19 of MET ).

•Patients with neuroblastoma.
•Other serious illnesses or medical conditions.
•Active uncontrolled infection.
•History of allergic reactions to the compounds or their solvents.
•Patients with untreated CNS metastases and/or primary CNS tumors and/or meningeal lymphoma involvement, defined as CNS3 status (patients with CNS2 are eligible).
•Concurrent use of drugs or foods that are known CYP3A4 substrates with narrow therapeutic indices as well as medication with known QT\-prolongation see Appendix 2\.
•Use of drugs or foods that are known strong CYP3A4 inhibitors within 7 days prior to the first dose of crizotinib. The topical use of these medications (if appropriate), such as 2% ketoconazole cream, may be allowed.
•Use of drugs that are known potent CYP3A4 inducers within 12 days prior to first dose of crizotinib
•Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure or cerebrovascular accident including transient ischemic attack.
•Use of live vaccines within 30 days of first dosing