Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.
Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1
Availability of tumor sample:
Exclusion Criteria:
Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Cancer Hospital of Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Experimental
CT-707
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment