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) |
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
We found this trial at
6
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials