A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available
Hoffmann-La Roche
Summary
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.
Eligibility
- Age range
- Up to 17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the investigational F1CDx assay or based on pre-existing NGS test results * Disease status: prior treatment proven to be ineffective (i.e. relapsed or refractory), or for whom there is no satisfactory standard treatment available. Disease should be measurable and evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or Response Assessment in Neuro-oncology criteria (RANO) +/- bone marrow criteria for…
Interventions
- DrugAlectinib
Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle
Locations (33)
- Lucile Packard Children's HospitalPalo Alto, California
- Johns Hopkins All Children's HospitalSt. Petersburg, Florida
- University of Michigan, C.S. Mott Children's HospitalAnn Arbor, Michigan
- Children's MinnesotaMinneapolis, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio