Nothing new in this post....just re-stating info/timelines from the four most recent posted Zenith slide decks starting with the Annual Meeting in December 2016....focusing on the status of the single agent ZEN-3694 trial since the ZEN-3694/enzalutamide combo is still in dose escalation stage as of June 20 2016. Based on the info in the slides, here's where we stand now for the single agent trial:
- It has been 7 months since confirming the MTD with every day dosing.
- Longest patient on drug should now be at around 12 months (assuming the patient is still alive).
- It has been 5 months since an intermittent dosing cohort was initiated. This may have just been a small cohort and it is unclear to me whether intermittent dosing was chosen as the recommended Phase 2 Dose
- Dose expansion cohort at recommended Phase 2 dose initiated about a month ago. As stated above, unclear if this dosing is every day or intermittent dosing.
- If intermittent dosing was chosen for expansion cohort, are those patients who were in the dose escalation portion of the trial continuing on every day dosing at a tolerable dose? Or are they being switched to the intermittent dosing?
December 15, 2016 (and same info re-iterated January 9, 2017): Maximum Tolerated Dose (MTD) confirmation; Longest patient on drug beyond 4 months; Intermittent dosing schedule cohorts may be initiated in Q1/17 for recommended Phase 2 dose (in discussion)
February 14, 2017: Longest patient on drug now beyond 6 months; Cohort with intermittent dosing has been initiated for recommended Phase 2 dose
June 20th, 2017: Recommended Phase 2 dose expansion cohort has been initiated; Longest patient on drug now beyond 11 months; Stable mediastinal nodes over past 10 months.
