Solid Tumors
Conditions
Keywords
INCB161734, KRASG12D Mutation, pancreatic ductal adenocarcinoma (PDAC), KRAS G12D inhibitor, KRAS inhibitor, KRAS mutation, pancreatic cancer, metastatic pancreatic cancer
Brief 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).
Interventions
DRUGINCB161734
Oral; tablet
DRUGPlacebo
Oral; tablet
The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response by BICR | Up to approximately 2 years | Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1. |
| Overall Survival (OS) | Up to approximately 3 years | Defined as the time from the date of randomization to the date of death due to any cause. |
| Progression-free survival (PFS) by BICR | Up to approximately 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) by BICR | Up to approximately 2 years | 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. |
| Disease control by BICR | Up to approximately 2 years | Defined as having CR, PR, or stable disease (SD) as the best response determined by BICR per RECIST v1.1. |
| Progression-Free Survival (PFS) by investigator assessment | Up to approximately 2 years | 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. |
| Objective response by investigator assessment | Up to approximately 2 years | Defined as CR or PR as determined by the investigator per RECIST v1.1. |
| 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 | Up to approximately 2 years | 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. |
| Disease control by investigator assessment | Up to approximately 2 years | Defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1. |
| Treatment Emergent Adverse Events (TEAEs) | Up to approximately 2 years and 30 days | 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. |
| TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment | Up to approximately 2 years and 30 days | TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment. |
| DOR by investigator assessment | Up to approximately 2 years | 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. |
| Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit | Up to approximately 2 years | 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. |
| Change from baseline in EQ-5D-5L score at each postbaseline visit | Up to approximately 2 years | 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). |
Countries
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed