The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Alectinib capsules 600 mg twice a day (BID) orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
Crizotinib capsules 250 mg BID orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with use of study drug, whether or not considered related to study drug. Preexisting conditions that worsened during study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug is reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events of special interest are cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of an infectious agent by study drug.
Time frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
Selected safety laboratory parameters include alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, alkaline phosphatase (ALP), and blood creatine phosphokinase (CPK). Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy is considered clinically significant.
Time frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Number and Causes of Death Occurring on Study
Once a patient has permanently discontinued study drug and completed the safety follow-up visit, no further survival data will be collected.
Time frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
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Chao Family Comprehensive Cancer Center
Orange, California, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Centre Francois Baclesse
Caen, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, France
Hopital Pontchaillou - CHU de Rennes
Rennes, France
CHU de Toulouse - Hôpital Larrey
Toulouse, France
Hopital Robert Schuman
Vantoux, France
...and 19 more locations