None listed
Conditions
Interventions
Drug : Phase 1b: About 3-6 patients enrollment is expected at dose level 1, -1 and -2. Dose reduction will be preceded with 3 patients/Level 1 cohort until the first DLT with 4 weeks’ observation. The
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion 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 ? 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
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 ? 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 ? 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. ? 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) ? Active infection including hepatitis B, hepatitis C ? Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recommend phase 2 dose | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Countries
Korea, Republic of
Contacts
Public ContactHyo Song Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed