A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Purpose

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).

Condition

  • Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
INCB161734 plus chemotherapy 		INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
  • Drug: INCB161734
    Oral; tablet
  • Drug: Investigator'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:
    Other names:
    • mFOLFIRINOX
    • GemNabP
Experimental
Placebo plus chemotherapy 		Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
  • Drug: Placebo
    Oral; tablet
  • Drug: Investigator'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:
    Other names:
    • mFOLFIRINOX
    • GemNabP

Recruiting Locations

Investigative Site US059
Lake Success, New York 11042

Investigative Site US060
Nashville, Tennessee 37203

Investigative Site US067
Dallas, Texas 75246

Investigative Site US062
Denison, Texas 75020

Investigative Site US063
San Antonio, Texas 78240

Investigative Site US064
Salem, Virginia 24153

Investigative Site PR001
Dorado, Puerto Rico 00646

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com