2024-12-13
2030-11-30
2030-11-30
610
NCT06608927
Arcus Biosciences, Inc.
Arcus Biosciences, Inc.
INTERVENTIONAL
Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-09-20 | N/A | 2025-04-08 |
2024-09-20 | N/A | 2025-04-09 |
2024-09-23 | N/A | 2024-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Arm A (Experimental Arm) Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion | DRUG: Quemliclustat
DRUG: Nab-paclitaxel
DRUG: Gemcitabine
|
| PLACEBO_COMPARATOR: Arm B (Comparator Arm) Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion | DRUG: Placebo
DRUG: Nab-paclitaxel
DRUG: Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 72 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 | Up to 72 months | |
| Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1 | Up to 72 months | |
| Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 | Up to 72 months | |
| Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1 | Up to 72 months | |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to 72 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Arcus Biosciences Phone Number: +1-510-462-3330 Email: ClinicalTrialInquiry@arcusbio.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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