A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
Incyte Corporation
Summary
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation * No prior systemic treatment in the metastatic setting * ECOG Performance status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with any KRAS inhibitor * Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug * Known active CNS metastases Other protocol-defined Inclusion/Exclusion Criteria may apply.
Interventions
- DrugINCB161734
Oral; tablet
- DrugPlacebo
Oral; tablet
- DrugInvestigator's choice of chemotherapy
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Locations (212)
- Investigative Site US058Birmingham, Alabama
- Investigative Site US016Anchorage, Alaska
- Investigative Site US026Chandler, Arizona
- Investigative Site US045Tucson, Arizona
- Investigative Site US051Duarte, California
- Investigative Site US048Fountain Valley, California