ALK-Rearranged Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : CH5424802/RO5424802
INN of investigational material : alectinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Inve
Sponsors
F. Hoffmann-La Roche, Ltd.
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Locally advanced or metastatic non-small cell lung cancer (NSCLC) - ALK-rearrangement confirmed by FDA approved test - Phase I: NSCLC that has failed crizotinib treatment - Phase II: NSCLC that has failed crizotinib and at least one line of platinum-based chemotherapy treatment - Measurable disease as defined by RECIST v1.1 - ECOG performance status </= 2 - Adequate hematologic, hepatic and renal function
Exclusion criteria
Exclusion criteria: - Prior therapy with an ALK inhibitor other than crizotinib - Brain metastases that are symptomatic and/or requiring treatment - History of serious cardiac dysfunction - History of or current active infection with hepatitis B, hepatitis C or HIV - Clinically significant gastrointestinal abnormality that would affect absorption of the drug - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Dose limiting toxicity Phase II: Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: PK parameters, Tumor response, Safety, and Clinical benefit, Phase II: Efficacy including CNS response and relapse rate, Safety, PK parameters, and Clinical benefit. | — |
Outcome results
None listed