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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
588
Oral; tablet
Oral; tablet
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 3 years
Progression-free survival (PFS) by BICR
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Time frame: Up to approximately 2 years
Objective Response by BICR
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of Response (DOR) by BICR
Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death from any cause.
Time frame: Up to approximately 2 years
Disease control by BICR
Defined as having CR, PR, or stable disease (SD) as the best response determined by BICR per RECIST v1.1.
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) by investigator assessment
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per RECIST v1.1 or death due to any cause.
Time frame: Up to approximately 2 years
Objective response by investigator assessment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigative Site US058
Birmingham, Alabama, United States
NOT_YET_RECRUITINGInvestigative Site US016
Anchorage, Alaska, United States
NOT_YET_RECRUITINGInvestigative Site US026
Chandler, Arizona, United States
NOT_YET_RECRUITINGInvestigative Site US045
Tucson, Arizona, United States
NOT_YET_RECRUITINGInvestigative Site US051
Duarte, California, United States
NOT_YET_RECRUITINGInvestigative Site US048
Fountain Valley, California, United States
NOT_YET_RECRUITINGInvestigative Site US049
Irvine, California, United States
NOT_YET_RECRUITINGInvestigative Site US054
La Jolla, California, United States
NOT_YET_RECRUITINGInvestigative Site US027
Los Angeles, California, United States
NOT_YET_RECRUITINGInvestigative Site US036
Los Angeles, California, United States
NOT_YET_RECRUITING...and 202 more locations
Defined as CR or PR as determined by the investigator per RECIST v1.1.
Time frame: Up to approximately 2 years
DOR by investigator assessment
Defined as the time from the earliest date of documented response until earliest date of disease progression as determined by the investigator per RECIST v1.1 or death from any cause.
Time frame: Up to approximately 2 years
Disease control by investigator assessment
Defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1.
Time frame: Up to approximately 2 years
Treatment Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.
Time frame: Up to approximately 2 years and 30 days
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
Time frame: Up to approximately 2 years and 30 days
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit
The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.
Time frame: Up to approximately 2 years
Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit
The EORTC QLQ-PAN26 consists of 26 questions that assess 9 pancreatic cancer-related and treatment-related symptoms (pain, eating-related items, cachexia, hepatic symptoms, side effects, altered bowel habits, ascites, indigestion, and flatulence) and 5 emotional domains specific to pancreatic cancer (body image, healthcare satisfaction, sexuality, fear of future health, and ability to plan for the future). The QLQ-PAN26 is scored on a 4-point scale that ranges from not at all to very much.
Time frame: Up to approximately 2 years
Change from baseline in EQ-5D-5L score at each postbaseline visit
The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: Up to approximately 2 years