Tasigna(nilotinib) is a second generation CML drug which will likely compete with Gleevec as a first line therapy option for Ph+ CML patients.

http://www.novartis.com/newsroom/media-r...

Tasigna's initial Phase 1 trial was in May of 2006. It was an intervential, non-Randomized, open label trial with an enrollment of 18 patients. Novartis presented their initial findings at the December 2006 ASH conference and started their phase 3 registration trial that same month (just 8 months after starting their phase 1 trial).

I believe this is the blueprint Ariad is using for 534.

tasigna phase 1 trial - http://www.clinicaltrials.gov/ct2/show/N...

tasigna phase 3 trial- http://www.clinicaltrials.gov/ct2/show/N...

Ariad 534 phase 1 trial - http://www.clinicaltrials.gov/ct2/show/N...