Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With 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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Metastatic Pancreatic Ductal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

New Hyde Park

Clinical Research Alliance, New Hyde Park, New York, United States, 11042

Spokane

Summit Cancer Centers - Spokane Valley, Spokane, Washington, United States, 99208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 adverse events (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.
  • * Previously treated for locally advanced, unresectable PDAC.
  • * History of brain metastases or leptomeningeal metastases.
  • * Prior treatment with a CD73 antagonist or inhibitor.
  • * Underlying medical or psychiatric conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arcus Biosciences, Inc.,

Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

2030-11-30