Inflammatory Myofibroblastic Tumors (IMT), Neuroblastoma (NBL), Rhabdomyosarcoma (RMS), Other ALK/ROS1/MET-positive malignancies, Anaplastic Large Cell Lymphoma (ALCL)
Conditions
Brief summary
Dose Limiting Toxicities (DLT) during the first cycle of crizotinib, in combination with temsirolimus for stratum 2, overall response rate for stratum 1b and 3.
Detailed description
Stratum 2 only: Overall response rate defined as the number of patients achieving complete and partial responses by disease after 2 courses (8 weeks), Best overall response rate defined as best reported overall lesions response at different evaluation time points from the start of study treatment until disease progression, Plasma concentration time profiles, PK parameters for crizotinib and for temsirolimus, Progression-free survival (PFS), Overall survival
Interventions
DRUGCRIZOTINIB
DRUGTorisel 30 mg concentrate and solvent for solution for infusion
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities (DLT) during the first cycle of crizotinib, in combination with temsirolimus for stratum 2, overall response rate for stratum 1b and 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stratum 2 only: Overall response rate defined as the number of patients achieving complete and partial responses by disease after 2 courses (8 weeks), Best overall response rate defined as best reported overall lesions response at different evaluation time points from the start of study treatment until disease progression, Plasma concentration time profiles, PK parameters for crizotinib and for temsirolimus, Progression-free survival (PFS), Overall survival | — |
Countries
Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain
Outcome results
None listed