Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Abemaciclib
Product Code: LY2835219
Pharmaceutical Form: Tablet
INN or Proposed INN: abemaciclib
CAS Number: 1231929-97-7
Other descriptive name: ABEMACICLIB
Concentration unit: mg milli
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have a diagnosis of HR+, HER2- mBC Have all of the following: • Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy. • Prior treatment with chemotherapy for locally advanced or metastatic disease. • No prior treatment with CDK4 and CDK6 inhibitor. Have a performance status (PS) of =1 on the Eastern Cooperative Oncology Group (ECOG) scale (Oken et al. 1982) Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures, including keeping records in the electronic patient diary (e-diary) as required by study protocol. Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy. All patients who experienced diarrhea as a side effect of previous therapy must have recovered to =Grade 1 prior to enrollment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: are currently receiving treatment in a clinical study involving an investigational product or are enrolled into any other type of medical research judged not to be scientifically or medically compatible with this study. have a serious concomitant systemic disorder (for example, active infection or a GI disorder causing clinically significant symptoms such as nausea, vomiting or diarrhea [such as Crohn’s disease, ulcerative colitis], or profound immune suppression) or a serious preexisting medical condition (for example, history of major surgical resection involving the stomach or small bowel) that, in the opinion of the investigator, would compromise/preclude the patient’s ability to adhere to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and summarize incidence of severe diarrhea (=Grade 3) or prolonged Grade 2 diarrhea (defined as >7 days duration), including the incidence of dose reductions, dose interruptions, and/or treatment discontinuations due to severe diarrhea or prolonged Grade 2 diarrhea over the first 3 cycles when abemaciclib is administered: •with a meal •without a meal, taken in the modified fasted condition •without regard to food;Secondary Objective: To assess safety and toxicity profile of abemaciclib To evaluate the PK parameters of abemaciclib and its metabolites;Primary end point(s): •Incidence of severe diarrhea (=Grade 3) •Incidence of prolonged Grade 2 diarrhea (defined as >7 days duration) •Dose reductions due to diarrhea •Dose interruptions due to diarrhea •Treatment discontinuations due to diarrhea •Utilization of antidiarrheals (dose and duration);Timepoint(s) of evaluation of this end point: Patients will record daily information on the number of stools, diarrhea, use of loperamide and the timing of the abemaciclib intake relative to their meals in cycle 1-3. Dose reductions and medications will be evalutaed throughout the study by the investigators. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The safety endpoints evaluated will include, but are not limited to, the following: • Overall safety • incidence and severity of TEAEs, SAEs, deaths, and clinical laboratory abnormalities Steady state concentrations of abemaciclib and its metabolites LSN2839567 and LSN3106726;Timepoint(s) of evaluation of this end point: AE collection throughout study PK in cycles 1-3 | — |
Countries
Australia, Belgium, Russian Federation, Spain, Turkey, Ukraine
Contacts
Public ContactAna Arias
Lilly S.A.
Outcome results
None listed