A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma

Conditions

Pancreatic cancer, Metastatic Pancreatic ductal adenocarcinoma (mPDAC), Pancreatic ductal adenocarcinoma (PDAC)

Brief summary

Overall survival is defined as the time from date of randomization until the date of death from any cause.

Detailed description

Progression-free survival is defined as the time from the date of randomization until disease progression or death from any cause, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator., Objective response rate (ORR) is defined as the proportion of patients who have achieved best overall response of confirmed complete response (CR) or partial response (PR) to study therapy as assessed by the investigator according to RECIST 1.1., Duration of response is defined as the time from the first objective response (CR or PR) until the date of first documented disease progression or death, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator., Disease control rate is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 8 weeks from the date of randomization, as assessed by the investigator according to RECIST 1.1., The incidence and severity of adverse events and serious adverse events, and any clinically meaningful trends in safety parameters.

Related papers

No related papers found yet.

Interventions

DRUGGEMCITABINE

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGQuemliclustat

DRUGSALINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival is defined as the time from date of randomization until the date of death from any cause.	—

Secondary

Measure	Time frame
Progression-free survival is defined as the time from the date of randomization until disease progression or death from any cause, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator., Objective response rate (ORR) is defined as the proportion of patients who have achieved best overall response of confirmed complete response (CR) or partial response (PR) to study therapy as assessed by the investigator according to RECIST 1.1., Duration of response is defined as the time from the first objective response (CR or PR) until the date of first documented disease progression or death, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator., Disease control rate is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 8 weeks from the date of randomization, as assessed by the investigator according to RECIST 1.1., The incidence and severity of adverse events and serious adverse eve	—

Measure

Time frame

Progression-free survival is defined as the time from the date of randomization until disease progression or death from any cause, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator., Objective response rate (ORR) is defined as the proportion of patients who have achieved best overall response of confirmed complete response (CR) or partial response (PR) to study therapy as assessed by the investigator according to RECIST 1.1., Duration of response is defined as the time from the first objective response (CR or PR) until the date of first documented disease progression or death, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator., Disease control rate is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 8 weeks from the date of randomization, as assessed by the investigator according to RECIST 1.1., The incidence and severity of adverse events and serious adverse eve

—

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed