NCT01819389 - 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)

Gómez-Almaguer D, Tarín-Arzaga L, Cantú-Rodríguez O, Ceballos-López A
More about imatinib and nilotinib combination therapy in chronic myeloid leukemia. Acta Haematol. 2013;129(1):18-9. doi: 10.1159/000342455. Epub 2012 Sep 12.
Schöffski P, Reichardt P, Blay JY, Dumez H, Morgan JA, Ray-Coquard I, Hollaender N, Jappe A, Demetri GD
A phase I-II study of everolimus (RAD001) in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors. Ann Oncol. 2010 Oct;21(10):1990-8. doi: 10.1093/annonc/mdq076. Epub 2010 May 27.
Zhu GR, Ji O, Ji JM, Zhang YC, Wu Y, Yu H, Jiang PJ, Shen Q
Combining nilotinib and imatinib improves the outcome of imatinib-resistant blast phase CML. Acta Haematol. 2012;127(3):152-5. doi: 10.1159/000333107. Epub 2012 Jan 27.

Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.

Clinical trial NCT01819389 - References