NBB,
The trial has a April 2018 study completion date (see the trial description on ClinicalTrials.gov), but I don't think that necessarily means that they can't report any findings until then (since it is unblinded). Keep in mind that this is primarily a safety and tolerability trial.
From the trial description there are two primary outcome measures:
- For dose escalation only: Incidence of dose-limiting toxicities (DLT) [ Time Frame: Cycle 1 (Day 1 thru Day 28). A DLT is a treatment-related, clinically significant adverse event or laboratory abnormality occurring during the first cycle of treatment (Day 1 thru Day 28).
- For dose escalation and dose confirmation: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [ Time Frame: Up to 24 months ]
So they've completed primary outcome 1. How long do they have to go for primary outcome 2? Up to 24-months is rather vague. The longest patient on drug is now at around 12 months. Do they have to go another 12 months? Unclear to me.
Although they have completed the dose escalation portion and have identified the maximal tolerated dose, I believe that they are now in the dose confirmation stage (referred in the Zenith slides as recommended Phase 2 dose expansion cohort). How many patients and how long they want/need to go for the dose confirmation/expansion stage is unknown. If they decided on an everyday dosing, then I think that things could move faster since all patients were on everyday dosing during the dose escalation portion and were progressively moved to higher doses as the 3+3 dose escalation design proceeded.
But if they decided to move to intermittent dosing for recommended Phase 2 dose, then this might slow things down. They may or may not want patients previously on everyday dosing to proceed into the dose confirmation/expansion stage if they are choosing an intermittent dosing for recommended Phase 2. They might want drug naive patients for intermittent dose expansion/confirmation. Clarity from management on the chosen recommended Phase 2 dose would help here. Intermittent dosing was reported to be initiated in Feb 2017, so those patients receiving intermittent have only been on drug for up to 5 months (assuming that those patients previously on everyday dosing are not eligible to participate in intermittent dosing).
A lot of unknowns and some much needed clarity would be appreciated if managment could provide an update soon.
BearDownAZ
