Phase 1 Completed N=26 Basic Science

A Study of LY2835219 in Participants With Cancer

Neoplasm · Neoplasm Metastasis

Source: ClinicalTrials.gov NCT02117648 ↗

Enrolled (actual)

Serious AEs

19.8%

Results posted

Aug 2018

Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib — 2230; 6850 nanogram*hour/milliliter(mL) ng*h/mL

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib	2230; 6850	—
PRIMARY PK: Maximum Concentration (Cmax) of Abemaciclib	70.0; 84.3	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02117648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.