A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

Status:	Active, not recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/17/2019
Start Date:	February 29, 2016
End Date:	April 10, 2019

Effects of Multiple Doses of Abemaciclib on the Pharmacokinetics of Cytochrome P450 (CYP) 1A2, CYP2C9, CYP2D6, and CYP3A Substrates (Caffeine, Warfarin, Dextromethorphan, and Midazolam) in Cancer Patients

This study is known as a "drug interaction study" and is being done to see how abemaciclib
may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin,
dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant
will complete screening and four study periods, with the option to continue to receive
abemaciclib in a safety extension phase. All participants will complete a safety follow-up.

Inclusion Criteria:

- Have histological or cytological evidence of a diagnosis of cancer that is advanced
and/or metastatic

- Have adequate organ function

- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale

- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, immunotherapy, cancer-related hormonetherapy, and investigational
therapy) for at least 21 days for myelosuppressive agents or 14 days for
nonmyelosuppressive agents prior to receiving study drug and have recovered from the
acute effects of therapy(treatment related toxicity resolved to baseline), except for
residual alopecia

Exclusion Criteria:

- Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9,
CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end
of Period 2

- History or presence of significant bleeding disorders

- Have known active uncontrolled or symptomatic CNS metastases

- Have a primary liver tumor

- Have lymphoma or leukemia

We found this trial at

sites

Sarah Cannon Research Institute at HealthONE

Denver, Colorado 80218

Principal Investigator: Gerald Falchook

Phone: 720-754-2610

from

Denver, CO