NL-OMON54812
Recruiting
Phase 2
A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies;Study ITCC 053 - CRISP
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- cancer
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •1b en 2:Histologically or cytologically confirmed diagnosis of
- •relapsed/refractory ALCL, including first relapse, NBL or RMS
- •3: Histologically confirmed diagnosis of other solid tumor or lymphomas other
- •than 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.when stratum 1b is completed, ALCL
- •patients will be eligible to enroll into stratum 3
- •Age at enrolment \>\=1 year of age and \<\= 21 years
Exclusion Criteria
- •Other serious illnesses or medical conditions, • Current 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 potent CYP3A4
- •inducers or inhibitors CYP3A4 substrates with narrow therapeutic indices as
- •well as medication with known QT\*prolongation, •• 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.
Outcomes
Primary Outcomes
Not specified
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