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Multicenter, randomized, placebo-controlled, double-masked, multicenter phase III clinical trial of quemliclustat and chemotherapy compared to placebo and chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

THE AIM OF THIS STUDY IS TO DETERMINE WHETHER THE STUDY DRUGS, QUEMLICLUSTAT (ALSO KNOWN AS AB680) IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL CHEMOTHERAPY (GEM-NP), COMPARED TO A PLACEBO (SALINE SOLUTION CONTAINING NO ACTIVE INGREDIENTS) IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL CHEMOTHERAPY, WOULD BE SAFE AND EFFECTIVE IN TREATING PATIENTS WITH THE TYPE OF CANCER THEY HAVE.

Status
In recruitment
headquarters
Pamplona/Madrid

Technical Summary

  • MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED, MULTICENTER PHASE III CLINICAL TRIAL OF QUEMLICLUSTAT AND CHEMOTHERAPY COMPARED TO PLACEBO AND CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA.
  • Code EudraCT: 2024-513317-12-00
  • Protocol number: PRISM-1
  • Promoter: Arcus Biosciencies
  • Molecule/Drug: Quemliclustat (AB680)

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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