A Clinical Study Testing The Safety and Efficacy of CH5424802/RO5424802 in Patients With ALK Positive Non-Small Cell Lung Cancer

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01588028 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-075


CH5424802 is a newly invented, selective oral ALK inhibitor. In the Phase I portion, the goal is to determine the following: dose limiting toxicity, the maximum tolerated dose, pharmacokinetic (PK) parameters, and the recommended dose. In the Phase II portion, the efficacy of CH5424802 will be assessed at the recommended dose.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Leena Gandhi, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Alice Shaw, MD, PhD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - ECOG performance status =< 2 - Confirmed of ALK-positive NSCLC by FDA approved kit - NSCLC that has failed crizotinib treatment for Phase I and II A - Measurable disease defined by RECIST 1.1 - Adequate hematologic, hepatic, renal function Exclusion Criteria: - Prior therapy with an ALK inhibitor other than crizotinib - Brain metastases, which are symptomatic and/or requiring treatment - History of serious cardiac dysfunction - Clinically significant gastrointestinal abnormality that would affect the absorption of drug - Pregnant or a lactating woman
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