This trial is active, not recruiting.

Condition alk-rearranged non-small cell lung cancer
Treatment ch5424802
Phase phase 1
Target ALK
Sponsor Hoffmann-La Roche
Start date April 2012
End date September 2015
Trial size 36 participants
Trial identifier NCT01588028, AF002JG, NP28761


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
locally advanced or metastatic ALK-positive NSCLC patients who have failed crizotinib treatment
Oral capsules taken twice daily

Primary Outcomes

Phase I: Dose limiting toxicity
time frame: Phase I: April 2012 to September 2014

Secondary Outcomes

Phase I: Tumor regression effect, PK parameters
time frame: Phase I: April 2012 to September 2014

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - ECOG performance status =< 2 - Confirmed of ALK-positive NSCLC by FDA approved kit - NSCLC that has failed crizotinib treatment for Phase I - 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

Additional Information

Official title A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.