Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:39 AM
Ignite Modification Date:
2025-12-25 @ 4:39 AM
NCT ID:
NCT04965818
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed advanced cancer of any tumor type (Part 1) or NSCLC with a confirmed KRAS mutation as determined by local results (Part 2)
* Appropriate candidate for experimental therapy
* For patients in Part 2 only: Patient has radiographically measurable disease per RECIST 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Adequate cardiac function (Left ventricular ejection fraction (LVEF) ≥50% )
* Adequate organ function
* Must have tumor tissue specimen available (optional for patients in Part 1)
Exclusion Criteria:
* History or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
* Current evidence or history of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
* Known untreated central nervous system (CNS) metastases or history of uncontrolled seizures.
* Significant gastrointestinal disorder(s) that could interfere with absorption of futibatinib/binimetinib
* Patients who have neuromuscular disorders that are associated with elevated creatinine kinase (CK)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04965818
Study Brief:
Protocol Section:
NCT04965818