Open Actively Recruiting

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

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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 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.

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