Title
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

Description
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.

Objective
Primary Objective: To compare OS of quemliclustat + NP-Gem vs placebo + NP-Gem in all randomized patients.

Secondary Objectives:
-To compare PFS of quemliclustat + NP-Gem vs placebo + NP-Gem in all randomized patients.
-To assess additional measures of clinical activity in all randomized patients.
-To assess the safety and tolerability of quemliclustat or placebo in combination with NP-Gem in all randomized patients.

Treatment Drug: Quemliclustat
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Gemcitabine

Key Eligibility Inclusion Criteria:

Have histologically or cytologically confirmed PDAC that is metastatic.

Have not been previously treated for PDAC in the metastatic setting.



Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.

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.



Eastern Cooperative Oncology Group PS of 0 to 1.

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.

Applicable Disease Sites
Pancreas

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital