RE: Asktraders article29 Jun 2022 11:15
5Mossman - is that short hurting? You need to try harder.
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.
Objective response rate (ORR) [ Time Frame: Up to one year ]
ORR is defined as the proportion of patients achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Duration of Response (DoR) [ Time Frame: Up to one year ]
DoR is defined as the duration of time from date of first response to date of disease progression, as per RECIST v1.1
Progression-free-survival (PFS) [ Time Frame: Up to one year ]
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed disease progression or death, whichever occurs first, as per RECIST v1.1
Overall survival (OS) [ Time Frame: Up to one year ]
Overall survival (OS), defined as the date of first dose) to the occurrence of death from any cause
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