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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:April 2012
Contact:Reference Study ID Number: AF-002JG / NP28761 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. Only)

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A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer


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.


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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