RE: Another route to approval15 May 2023 15:03
Thanks Rah. This is what the trial protocol says:
Primary Outcome Measures :
Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1, 21 days ]
Percentage of patients with Dose-Limiting toxicities (DLTs) of AVA6000 during the DLT period [ Time Frame: Cycle 1, 21 days ]
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) [ Time Frame: Cycle 1, 21 days ]
Percentage of patients with Adverse Events (AEs) at RP2D AVA6000 dose level in tumour-specific expansion arms. [ Time Frame: Cycle 1, 21 days ]
Secondary Outcome Measures :
Maximum drug concentration (Cmax) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
Cmax (maximum plasma concentration) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Area under the concentration versus time curve (AUC) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
AUC (Area under the concentration versus time curve) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Elimination half-life (t1/2) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
t1/2 (Elimination half-life) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Renal clearance (CLr) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
CLr (Renal clearance) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
My (non-medial) reading is all the primary outcomes require 1 dose, plus 21 days? Secondary outcomes require 2 doses plus 72 hours? This reads to me like 24 days could be all that is needed from first dose to all data being obtained. This timeline would make completing 1a a quick turnaround? Assuming the success to date means potential patients are easy to find. Am i being optimistic and mis-reading this?