ALK-Rearranged Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer
| Verified date | October 2014 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 36 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase I: Dose limiting toxicity | Phase I: April 2012 to September 2014 | Yes | |
| Secondary | Phase I: Tumor regression effect, PK parameters | Phase I: April 2012 to September 2014 | Yes |