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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513317-12-00 | EU Trial (CTIS) Number | ||
| jRCT2061240084 | Other Identifier | Japan Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Taiho Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Experimental Arm) | Experimental | Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion |
|
| Arm B (Comparator Arm) | Placebo Comparator | Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quemliclustat | Drug | Administered as specified in the treatment arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 72 months |
| 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 |
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Inclusion Criteria:
Have histologically or cytologically confirmed PDAC that is metastatic.
Have not been previously treated for PDAC in the metastatic setting.
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:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Arcus Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85054 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| PRISM-1 - Public website | View source |
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Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
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| Placebo |
| Drug |
Administered as specified in the treatment arm |
|
| Nab-paclitaxel | Drug | Administered as specified in the treatment arm |
|
| Gemcitabine | Drug | Administered as specified in the treatment arm |
|
| 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 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Research Site | La Jolla | California | 92093 | United States |
| Research Site | Los Alamitos | California | 90720 | United States |
| Research Site | Los Angeles | California | 90033-5315 | United States |
| Research Site | Roseville | California | 95661 | United States |
| Research Site | San Francisco | California | 94158 | United States |
| Research Site | Santa Monica | California | 90404 | United States |
| Research Site | Denver | Colorado | 80218 | United States |
| Research Site | New Haven | Connecticut | 06520 | United States |
| Research Site | Jacksonville | Florida | 32224-1865 | United States |
| Research Site | Miami | Florida | 33176 | United States |
| Research Site | Atlanta | Georgia | 30318 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Arlington Heights | Illinois | 60005 | United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Wichita | Kansas | 67208 | United States |
| Research Site | Baton Rouge | Louisiana | 70809 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Grand Rapids | Michigan | 49503 | United States |
| Research Site | Minneapolis | Minnesota | 55404 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | Hattiesburg | Mississippi | 39401 | United States |
| Research Site | Kansas City | Missouri | 64111 | United States |
| Research Site | Omaha | Nebraska | 68105 | United States |
| Research Site | New Brunswick | New Jersey | 08903-2681 | United States |
| Research Site | Buffalo | New York | 14263 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | New York | New York | 10128 | United States |
| Research Site | Rochester | New York | 14642 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Research Site | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Austin | Texas | 78705 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Dallas | Texas | 75390 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | San Antonio | Texas | 78240 | United States |
| Research Site | Webster | Texas | 77598 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Seattle | Washington | 98101 | United States |
| Research Site | Spokane | Washington | 99208 | United States |
| Research Site | Vancouver | Washington | 98684 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | Camperdown | Australia |
| Research Site | Clayton | Australia |
| Research Site | Murdoch | Australia |
| Research Site | Wollongong | Australia |
| Research Site | Salzburg | Austria |
| Research Site | Sankt Pölten | Austria |
| Research Site | Vienna | Austria |
| Research Site | Anderlecht | Belgium |
| Research Site | Bonheiden | Belgium |
| Research Site | Kortrijk | Belgium |
| Research Site | Ottawa | Canada |
| Research Site | Sherbrooke | Canada |
| Research Site | Toronto | Canada |
| Research Site | Brno | Czechia |
| Research Site | Nový Jičín | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Dijon | France |
| Research Site | Lille | France |
| Research Site | Lyon | France |
| Research Site | Poitiers | France |
| Research Site | Villejuif | France |
| Research Site | Bochum | Germany |
| Research Site | Frankfurt am Main | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Hanover | Germany |
| Research Site | Heilbronn | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Riesa | Germany |
| Research Site | Ulm | Germany |
| Research Site | Würzburg | Germany |
| Research Site | Bologna | Italy |
| Research Site | Cremona | Italy |
| Research Site | Florence | Italy |
| Research Site | Milan | Italy |
| Research Site | Modena | Italy |
| Research Site | Padova | Italy |
| Research Site | Piacenza | Italy |
| Research Site | Roma | Italy |
| Research Site | Rozzano | Italy |
| Research Site | Torrette | Italy |
| Research Site | Verona | Italy |
| Research Site | Kashiwa-shi | Japan |
| Research Site | Kōtō City | Japan |
| Research Site | Osaka | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Toyama | Japan |
| Research Site | Ube | Japan |
| Research Site | Yokohama | Japan |
| Research Site | Hwasun | South Korea |
| Research Site | Seongnam | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Barcelona | Spain |
| Research Site | Elche | Spain |
| Research Site | Girona | Spain |
| Research Site | Madrid | Spain |
| Research Site | Pamplona | Spain |
| Research Site | Vigo | Spain |
| Research Site | Zaragoza | Spain |
| Research Site | Birmingham | United Kingdom |
| Research Site | Cottingham | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000723779 | quemliclustat |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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