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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.

Primary:
- To compare OS of quemliclustat + NP-Gem versus placebo + NP-Gem in all randomized patients.

- To compare progression-free survival (PFS) of quemliclustat + NP-Gem versus placebo + NP-Gem in all randomized patients.

Secondary:
- To assess additional measures of clinical activity in all randomized patients.

- To assess the safety and tolerability of quemliclustat or placebo in combination with NP Gem in all randomized patients.

Protocol Number: 072402
Phase: Phase III
Applicable Disease Sites: Pancreas
Drugs Involved: Quemliclustat
Principal Investigator: Howard Hochster
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Cooperman Barnabas, Livingston
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
    • Trinitas Hospital and Comprehensive Cancer Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.