A phase IB study of crizotinib in pediatric malignancies
Recruiting
- Conditions
- children, cancer, pediatric malignancies, ALK positive tumors, ROS1 positive tumors, MET positive tumorskinderen, kanker, pediatrische maligniteiten, tumoren positief voor ALK, ROS1, MET afwijkingen
- Registration Number
- NL-OMON24969
- Lead Sponsor
- niversity Medical Center Erasmus Medical Center Rotterdam The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 82
Inclusion Criteria
Inclusion criteria stratum 1
• Histologically or cytologically confirmed diagnosis of ALCL
Exclusion Criteria
• Other serious illnesses or medical conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Dose Limiting Toxicities (DLT) during the first cycle of crizotinib, in combination with either vinblastine, temsirolimus for stratum 1 and 2.<br /><br>• Overall response rate (descriptive) for stratum 3.
- Secondary Outcome Measures
Name Time Method • Overall response rate defined as the number of patients achieving complete and partial responses by disease after 2 courses (8 weeks). <br /><br>• Overall response rate defined as the number of patient achieving complete and partial response during the total study period. <br /><br>• Plasma concentration time profiles, PK parameters, including but not limited to AUClast, AUCtau, Cmin, Cmax, Tmax, Racc, and T1/2,acc for crizotinib, temsirolimus and vinblastine. <br /><br>• Progression-free survival (PFS)