Vanderbilt Clinical Trials

Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Purpose

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.

Condition

Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Have histologically or cytologically confirmed PDAC that is metastatic. - Have not been previously treated for PDAC in the metastatic setting. 1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. 2. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and AEs have resolved to Grade 1 or less before randomization. 3. 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.

Exclusion Criteria

Previously treated for locally advanced, unresectable PDAC. - History of brain metastases or leptomeningeal metastases. - Prior treatment with a CD73 antagonist or inhibitor. - Underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A (Experimental Arm)	Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion	Drug: Quemliclustat Administered as specified in the treatment arm Drug: Nab-paclitaxel Administered as specified in the treatment arm Drug: Gemcitabine Administered as specified in the treatment arm
Placebo Comparator Arm B (Comparator Arm)	Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion	Drug: Placebo Administered as specified in the treatment arm Drug: Nab-paclitaxel Administered as specified in the treatment arm Drug: Gemcitabine Administered as specified in the treatment arm

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status: Recruiting
Sponsor: Arcus Biosciences, Inc.

Study Contact

Arcus Biosciences
+1-510-462-3330
ClinicalTrialInquiry@arcusbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.