A Clinical Study Testing The Safety and Efficacy of CH5424802/RO5424802 in Patients with ALK Positive Non-Small Cell Lung Cancer
- Conditions
- ALK-Rearranged Non-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080221778
- Lead Sponsor
- F. Hoffmann-La Roche, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 121
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 - Adequate hematologic, hepatic and renal function
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Dose limiting toxicity<br>Phase II: Response Rate
- Secondary Outcome Measures
Name Time Method Phase I: PK parameters, Tumor response, Safety, and Clinical benefit,<br>Phase II: Efficacy including CNS response and relapse rate, Safety, PK parameters, and Clinical benefit.