This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.
Science 37, Inc
Culver City, California, United States
Science 37-Basem; Dept 004- Basem
Culver City, California, United States
Science 37-Beg; Dept 001 Dr. M. Beg
Culver City, California, United States
Science 37-Cannon; Dept 002-Cannon
Culver City, California, United States
Science 37-Kurzrock; Dept 005-Kurzrock
Culver City, California, United States
Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Approximately 1 year
Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
Time frame: 0 days
Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1
Time frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1
Time frame: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
Time frame: Baseline up to 5 years
CNS DOR by BICR Per RECIST v1.1
Time frame: From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
Overall Survival (OS)
Time frame: From the first dose of study drug to death from any cause (up to 5 years)
Percentage of Participants With Adverse Events (AEs)
Time frame: Approximately 1 year
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Approximately 1 year
Plasma Concentration of Alectinib
Time frame: Baseline up to 5 years
ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria
Time frame: Up to 5 years
DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria
Time frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria
Time frame: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
OS in Participants With Primary CNS Tumors
Time frame: From the first dose of study drug to death from any cause (up to 5 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Science 37-Thomas; Dept 006-Thomas
Culver City, California, United States
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