A phase I/II study of crizotinib for recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and phase I study of this drug for recurrent or refractory neuroblastoma
- Conditions
- Recurrent or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma. Recurrent or refractory neuroblastoma
- Registration Number
- JPRN-UMIN000028075
- Lead Sponsor
- St. Marianna University School of Medicine Hospital National Center for Child Health and Development Nagoya Medical Center Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 23
Not provided
[Phase 1/2 parts] 1) Patients with CNS (central nervous system)disease. 2) Primary cutaneous ALCL. 3) Pregnant or brest-feeding women. 4) Patients of reproductive potential who have not agreed to use an effective contraception method. 5) Patients receiving the following concomitant medications 5-1) Therapeutic corticosteroids for lymphoma 5-2) investigational instruments and clinical trial products. 5-3) Anticancer agents 5-4) narrow therapeutic indice CYP3A4 substrates 5-5) Strong CYP3A4 inhibitors 5-6) Strong CYP3A4 inducers 6) Patients with interstitial fibrosis or interstitial lung disease or with a known history of those. 7) Patients with myocardial infarction or cerebrovascular disorder or with a known history of those. 8) Patients having an uncontrolled infectious disease. 9) Those who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. 10) Patient who can not take capsule formulation or liquid formulation. However, administration of the liquid preparation via the feeding tube is permitted.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method