A Study of LY2835219 in Participants With Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | April 2014 |
| End Date: | August 2015 |
Effects of CYP3A Inhibition by Clarithromycin on the Pharmacokinetics of LY2835219 and Its Metabolites in Cancer Patients
The purpose of this study is to assess how the body handles Abemaciclib when it is given with
another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib
that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from
the body. The safety and tolerability of these drugs will be studied.
Each participant will complete 2 study periods in fixed order. After screening, Period 1 will
last approximately 8 days and Period 2 will last approximately 15 days. Participants who
complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation
criteria are met.
another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib
that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from
the body. The safety and tolerability of these drugs will be studied.
Each participant will complete 2 study periods in fixed order. After screening, Period 1 will
last approximately 8 days and Period 2 will last approximately 15 days. Participants who
complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation
criteria are met.
Inclusion Criteria:
- Have histological or cytological evidence of cancer (solid tumors) that is advanced
and/or metastatic
- Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)
scale
Exclusion Criteria:
- No symptomatic central nervous system (CNS) malignancy or metastasis
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