EUCTR2015-005437-53-ES
Active, not recruiting
Phase 1
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
ConditionsChildren with malignancies carrying a genetic alteration of ALK, MET or ROS1 with no better treatment options according to the current (inter)national guidelinesTherapeutic area: Diseases [C] - Cancer [C04]
DrugsXalkori
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Children 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
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed diagnosis of ALCL
- ••Target gene aberration as defined as:
- •oThe t(2;5\) translocation or other translocation encoding for ALK aberrations (e.g. (1;2\), t(2;3\), inv(2\), t(2;22\)) This should be apparent in all tumor cells
- •?This can be proven by either ALK\- immunohistochemistry, FISH or PCR
- •Disease involvement:
- •o For dose escalation measurable and non measurable disease is allowed
- •o For does expansion measurable disease is mandated
- •o Measurable disease is defined as at least one nodule with a longest diameter
- •greater than 1\.5 cm
- •Histologically or cytologically confirmed diagnosis NBL or RMS
Exclusion Criteria
- •Other serious illnesses or medical conditions
- •Current uncontrolled infection
- •History of allergic reactions to the compounds or their solvents
- •Patients with known 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 as
- •well as medication with known QT\-prolongation
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the
- •absorption of crizotinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea,
- •or malabsorption syndrome)
Outcomes
Primary Outcomes
Not specified
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