A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
- Registration Number
- NCT04774718
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALK-Fusion Positive Alectinib Part 1 is a dose-confirmation phase to confirm the recommended phase 2 dose (RP2D). In Parts 2 and 3, participants will receive alectinib at the RP2D on Days 1-28 of each 28-day cycle
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events Up to 10 years Incidence of Participants with Dose-Limited Toxicities (DLTs) Cycle 1 (cycle length = 28 days) Plasma Concentration of Alectinib 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) Up to 10 years Plasma Concentration of Alectinib Metabolite (M4) Up to 10 years
- Secondary Outcome Measures
Name Time Method Time to Response (TTR) as Determined by BICR and the Investigator From the first dose of alectinib to the first documentation of objective response (CR or PR) (up to 10 years) Confirmed ORR as Determined by the Investigator Up to 10 years Progression-Free Survival (PFS) as Determined by BICR and the Investigator 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) From the first dose of alectinib to the date of death due to any cause (up to 10 years) Duration of Response (DOR) as Determined by BICR and the Investigator 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) Clinical Benefit Rate (CBR) as Determined by BICR and the Investigator 6 months after the first dose of alectinib
Trial Locations
- Locations (33)
Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States
Children's Minnesota
🇺🇸Minneapolis, Minnesota, United States
Hospital de Cancer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Rigshospitalet
🇩🇰København Ø, Denmark
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
🇫🇷Paris, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Istituto Nazionale Tumori di Milano
🇮🇹Milano, Lombardia, Italy
Dipartimento di Scienze Pediatriche Adolescenza
🇮🇹Torino, Piemonte, Italy
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
University of Michigan, C.S. Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
St. Jude Children'S Research Hospital
🇺🇸Memphis, Tennessee, United States
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
🇧🇷Sao Paulo, São Paulo, Brazil
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique
🇫🇷Lyon, France
Hôpital de la Timone, Oncologie Pédiatrique
🇫🇷Marseille, France
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS
🇮🇹Genova, Liguria, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Infantil Universitario Nino Jesus
🇪🇸Madrid, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Great Ormond Street Hospital
🇬🇧London, United Kingdom
Royal Manchester Childrens Hospital
🇬🇧Manchester, United Kingdom
Great North Children's Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Royal Marsden Hospital (Sutton)
🇬🇧Sutton, United Kingdom