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
Contact:
NCT Number:
Protocol:
AAAV5505
Study Status:
Active/Enrolling
Population:
Adult
Phase:
III
The purpose of this research is to determine the safety and efficacy of investigational study drug quemliclustat (also known as AB680) in combination with chemotherapy gemcitabine and nab-paclitaxel (Gem-NP), compared to a placebo (saline solution not containing treatment drug) in combination with chemotherapy gemcitabine and nab-paclitaxel at treating participants with the type of cancer you have. Quemliclustat has not been approved by the Food and Drug Administration (FDA). Gemcitabine and nab-paclitaxel (Gem-NP) is FDA approved but not in combination with quemliclustat. This is a double-blinded study. This means neither you, the study doctor, nor the study team will know whether you are receiving quemliclus
Are you Eligible? (Inclusion Criteria)
- Must be 18 years old or older - No major surgery within 28 days prior to start of treatment - Must be able to comply with study procedures and study visits
Specialty Area(s)
Pancreatic Cancer, Immunotherapy
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032