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

Eli Lilly and Company48 enrolled

Overview

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 in a fixed sequence, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Neoplasm Metastasis

Interventions

Drug CocktailDRUG

Administered orally

AbemaciclibDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 hormone therapy, 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

Locations (5)

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States

IU Simon Cancer Center

Indianapolis, Indiana, United States

University of Kansas Hospital

Fairway, Kansas, United States

Mary Crowley Cancer Research Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine

Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.

Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose

Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin

Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.

Time frame: Days 1 and 8: Predose, 0.5 1, 2, 3, 4, 6, 8, 12, 48, 72, 96 hr Postdose

Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan

Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.

Time frame: Days 1 and 8: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72 hr postdose

Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam

Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.

Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose

Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Caffeine

PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.

Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hr Postdose

Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of S-Warfarin

AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.

Data from ClinicalTrials.gov

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Secondary Outcomes

Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1

Mean change from predose in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose drug cocktail in Period 1.

Time frame: Day 8: Baseline, 24 h postdose

Mean Change From Baseline at 24 Hours in Pulse Rate in Period 1

Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 1.

Time frame: Day 8: Baseline, 24 h postdose

Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2

Mean change from baseline in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose of abemaciclib in Period 2, Day 1.

Time frame: Day 1: Baseline, 24 h postdose

Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2

Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 2, Day 1.

Time frame: Day 1: Baseline, 24 h postdose

Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2

Mean change from baseline in systolic and diastolic blood pressure (BP) at 24 h postdose following 200 mg abemaciclib and drug cocktail.

Time frame: Day 8: Baseline, 24 h postdose

Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2

Mean change from baseline in pulse rate at 24 h postdose following 200 mg abemaciclib and drug cocktail.

Time frame: Day 8: Baseline, 24 h postdose