EUCTR2015-005437-53-DK
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 malignanciesStudy ITCC 053 - CRISP
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus Medical Center
- Enrollment
- 71
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria stratum 1b
- •Histologically or cytologically confirmed diagnosis of relapsed/refractory ALCL, including first relapse
- •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:
- •oThe t(2;5\) translocation or rearrangement t(1;2\), t(2;3\), inv(2\), t(2;22\). This should be apparent in all tumor cells
- •?This can be proven by ALK\- immunohistochemistry, FISH or NGS
- •Life expectancy ? 12 weeks
- •Disease involvement :
- •oMeasurable disease defined as at least one nodule with a longest diameter greater than 1\.5 cm (pediatric NHL response criteria) \[Sandlund 2015]
Exclusion Criteria
- •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 potent CYP3A4 inducers or inhibitors, CYP3A4 substrates with narrow therapeutic indices as well as medication with known QT\-prolongation see Appendix 2
- •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
- •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)
- •Not able to comply with scheduled follow\-up and with management of toxicity.
- •A cardiac shortening fraction \< 29%
Outcomes
Primary Outcomes
Not specified
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