Protocol
11-055
Full Title
A Phase I, Multicenter, Open-label Dose Escalation Study of LDK378, Administered Orally in Adult Patients with Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)
Purpose
ALK is a gene that can fuse with others genes to form a “gene fusion product” that promotes the growth of non-small cell lung cancer (NSCLC). For example, about 5 percent of NSCLC patients have a fusion of ALK with a gene called EML4.
In this study, researchers are evaluating an investigational drug called LDK378 in patients with NSCLC who have an ALK gene fusion and whose cancer has continued to grow despite therapy. LDK378 is designed to inhibit the cancer-promoting activity of the ALK gene fusion product. LDK378 is a capsule that is taken orally (by mouth).
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have locally advanced or metastatic NSCLC that has progressed despite standard therapy.
- Patients’ cancers must have an ALK gene fusion.
- At least 2 weeks must have passed since prior chemotherapy (including crizotinib) or major surgery and 3 weeks since any radiation therapy and entry into the study.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Gregory Riely at 646-888-4199.
Disease(s)
Lung Cancer
Lung Cancer, Non-Small Cell
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma
Locations
Related Diseases
