A phase IB/II study of abemaciclib with paclitaxel for CDK4/6 pathway activated tumors
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
? 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
? 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method