NCT01662635 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Jemal A, Freddie Bray, Melissa M, et al
Cancer statistics, 2011. CA Cancer J Clin. 61: 69-90, 2011. Wong DW. The EML4-ALK Fusion Gene Is Involved in Various Histologic Types of Lung Cancers From Non smokers With Wild-type EGFR and KRAS. Cancer 15, 1723-1733, 2009. Shaw, A. T. et al. Clinical Features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J. Clin. Oncol. 27, 4247-4253 2009. Kwak, E. L. et al. Anaplatic lymphoma kinase Inhibition in non-small cell lung cancer. N. Engl. J. Med. 363, 1693- 1703 2010. Soda M., Takada, S., Takeuchi, K., Choi, Y.L., Enomoto, M., Ueno, T. et al. A mouse model for EML4-ALK- positive lung cáncer. Proc Natl Acad Sci U S A 105: 19893-19897, 2008.

CLINICOPATHOLOGICAL FEATURES OF NON-SMALL CELL LUNG CANCER PATIENTS ASSOCIATED WITH THE CHOROMOSOME 2p (EML4-ALK) INVERSION IN MEXICAN POPULATION.

Clinical trial NCT01662635 - References