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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT04594005
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed locally advanced or metastatic solid tumors, for which standard therapy proven to provide clinical benefit no longer
* CDK4/6 activated tumors on next-generation sequencing or FISH (fluorescence in situ hybridization) analyses
\- CCND1, 2, or 3 high-level amplification, CCND1 mutation, or a CCND1 splice variant expected to lead to nuclear retention of cyclin D1 protein
\- CDK4 or CDK6 high-level amplification
* ECOG performance status of 0 to 1
* ≥ 19 years of age
* Subjects with measurable or evaluable disease ⑥ Subjects who meet the following criteria: - Absolute neutrophil count (ANC) ≥ 1500 /µL (\*ANC = Neutrophil segs ＋ Neutrophil bands) - Platelet count ≥ 75,000/ µL - Serum creatinine \< 1.5 x upper limit of normal (ULN)
* AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal (ULN) (If there is Liver Metastasis \< 5 x upper limit of normal (ULN))
* Total bilirubin \< 1.5 x upper limit of normal (ULN)
* Provision of written informed consent prior to any study procedure
Exclusion Criteria:
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
* Any previous chemotherapy or immunotherapy within 2 weeks or at least 3-5 half-lives for previous chemo/immunotherapy whichever is longer.
* Any major operation or irradiation within 2 weeks of baseline disease assessment
* Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
* Previously abemaciclib-exposed patients
⑥ Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
⑦ Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
⑧ Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
⑨ Active infection including hepatitis B, hepatitis C
⑩ Pregnant or lactating female
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04594005
Study Brief:
Protocol Section:
NCT04594005