The purpose of this study is to determine a safe dose of Abemaciclib to be given to participants with advanced cancer and to determine any side effects that may be associated with Abemaciclib in this population. Efficacy measures will be used to assess the activity of Abemaciclib in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Administered orally.
Fulvestrant is administered intramuscularly into the buttocks in Part G only.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Monica, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Boston, Massachusetts, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Number of Participants With Clinically Significant Effects
The number of participants with clinically significant findings in the study were reported in this outcome measure.
Time frame: Baseline up to 233 weeks
Percentage of Participants With Tumor Response - Overall Response Rate (ORR), Disease Control Rate (DCR)
ORR is the percentage of participants who exhibit a confirmed complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. DCR is defined as the percentage of participants in the analysis population who exhibit a stable disease (SD) or confirmed CR or PR relative to baseline during the study. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Time frame: Baseline through Study Completion (Up to 285 weeks)
Pharmacokinetics (PK): Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib
PK: Cmax,ss of Abemaciclib.
Time frame: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
PK: Area Under the Steady State Plasma Concentration-time Curve Over 24 Hours (AUC 0-24hr,ss) of Abemaciclib
PK: AUC 0-24hr,ss of Abemaciclib.
Time frame: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
Part A: Recommended Dose for Phase 2 Studies
The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
San Antonio, Texas, United States
Time frame: Baseline through Study Completion (Up to 285 weeks)