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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle
Incidence of Participants with Dose-Limited Toxicities (DLTs)
Time frame: Cycle 1 (cycle length = 28 days)
Percentage of Participants with Adverse Events
Time frame: Up to 10 years
Plasma Concentration of Alectinib
Time frame: Up to 10 years
Plasma Concentration of Alectinib Metabolite (M4)
Time frame: Up to 10 years
Confirmed Objective Response Rate (ORR): Defined as the Proportion of Participants with Complete Response (CR) or Partial Response (PR) on two Consecutive Occasions >/= 4 Weeks Apart, as Determined by Blinded Independent Central Review (BICR)
Time frame: Up to 10 years
Confirmed ORR as Determined by the Investigator
Time frame: Up to 10 years
Duration of Response (DOR) as Determined by BICR and the Investigator
Time frame: From the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first (up to 10 years)
Time to Response (TTR) as Determined by BICR and the Investigator
Time frame: From the first dose of alectinib to the first documentation of objective response (CR or PR) (up to 10 years)
Clinical Benefit Rate (CBR) as Determined by BICR and the Investigator
Time frame: 6 months after the first dose of alectinib
Progression-Free Survival (PFS) as Determined by BICR and the Investigator
Reference Study ID Number: GO42286 https://forpatients.roche.com/
CONTACT
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Lucile Packard Children's Hospital
Palo Alto, California, United States
RECRUITINGJohns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
RECRUITINGUniversity of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
RECRUITINGChildren's Minnesota
Minneapolis, Minnesota, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
ACTIVE_NOT_RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGSt. Jude Children'S Research Hospital
Memphis, Tennessee, United States
RECRUITINGSydney Children's Hospital
Randwick, New South Wales, Australia
RECRUITINGRoyal Children's Hospital
Parkville, Victoria, Australia
RECRUITINGHospital de Cancer de Barretos
Barretos, São Paulo, Brazil
RECRUITING...and 23 more locations
Time frame: From the first dose of alectinib to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 10 years)
Overall Survival (OS)
Time frame: From the first dose of alectinib to the date of death due to any cause (up to 10 years)