enEnglisch
CRISP
A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies
A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies
Recruiting
Summary
The aim of this study is to determine what is a safe dose of the drug crizotinib when
given alone, and when given in combination with temsirolimus. Furthermore, it will be investigated how the patients respond to the treatment, and what side effects may
result from the treatment.
All patients will need to undergo a biopsy to obtain tumor material at the start of the if no
archival samples are available.
Crizotinib can be taken as capsules or pellets. Patients will be treated with crizotinib for a maximum of 12 cycles; cycle length is 28 days.
The medication administration can be done at home.
Study visits will be weekly during the first 2 cycles of the study. From cycle 3 up to and including cycle 12, study visits will be done every other week if no significant safety issues are encountered in the first 2 cycles.
Main inclusion criteria
- Age ≥1 and ≤ 21 years
- Confirmed diagnosis of relapsed/refractory solid
tumors (excluding neuroblastoma) or lymphomas (including ALCL) that
is relapsed or refractory to standard therapy
- Patients with newly diagnosed inflammatory myofibroblastic tumors (IMT) for
whom surgery may not be feasible for close proximity to vital structures, without prior
tumor-shrinkage and no other feasible options are available as per local standard of care
- Karnofsky oder Lansky > 50
Sponsor
Princess Máxima Center for Pediatric Oncology, Netherlands