NIPH Clinical Trials Search

Randomized Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Metastatic pancreatic ductal adenocarcinoma (mPDAC)
Date of first enrollment	20/01/2025
Target sample size	50
Countries of recruitment	United States,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,France,Japan,Germany,Japan,Italy,Japan,Republic of Korea,Japan,Spain,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	Arm A (Experimental Arm) Quemliclustat, Nab-paclitaxel, and Gemcitabine will be administered by injection. Arm B (Comparator Arm) Placebo, Nab-paclitaxel, and Gemcitabine will be administered by injection.

Outcome(s)

Primary Outcome	Overall survival (OS)
Secondary Outcome	Progression-free Survival (PFS) Objective response rate (ORR) Duration of response (DoR) Disease Control Rate (DCR) The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Have histologically or cytologically confirmed PDAC that is metastatic. 2. Have not been previously treated for PDAC in the metastatic setting. a. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. b. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and adverse events (AEs) have resolved to Grade 1 or less before randomization. Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade <= 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction. 3. Eastern Cooperative Oncology Group PS of 0 to 1 within 7 days of randomization. 4. At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.
Exclude criteria	1.Previously treated for locally advanced, unresectable PDAC. 2.History of brain metastases or leptomeningeal metastases. 3.Prior treatment with a CD73 antagonist or inhibitor. 4.Underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous.