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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-08

Study Completion Date

2021-01-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Drug Cocktail - Period 1

Single dose of drug cocktail: 100 milligram (mg) caffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.

Group Type ACTIVE_COMPARATOR

Drug Cocktail

Intervention Type DRUG

Administered orally

200 mg Abemaciclib + Drug Cocktail - Period 2

200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 - 12 in Period 2 with a single dose of drug cocktail: 100 mgcaffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.

Group Type EXPERIMENTAL

Drug Cocktail

Intervention Type DRUG

Administered orally

Abemaciclib

Intervention Type DRUG

Administered orally

200 mg Abemaciclib - Period 3

200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3. Participants may continue to receive abemaciclib until discontinuation criteria are met.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

200 mg Abemaciclib - Period 4

200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4. Participants may continue to receive abemaciclib until discontinuation criteria are met.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Safety Extension Period

200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period. Participants may continue to receive abemaciclib until discontinuation criteria are met.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Interventions

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Drug Cocktail

Administered orally

Intervention Type DRUG

Abemaciclib

Administered orally

Intervention Type DRUG

Other Intervention Names

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Caffeine + Warfarin + Dextromethorphan + Midazolam LY2835219

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No