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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT02688088

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

9.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis	Drug: Drug Cocktail Drug: Abemaciclib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 8, 2016

Actual Primary Completion Date :

Feb 4, 2018

Actual Study Completion Date :

Jan 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Drug Cocktail Single dose of drug cocktail (caffeine, warfarin, dextromethorphan, and midazolam) administered orally on Day 1 of Period 1.	Drug: Drug Cocktail Administered orally Other Names: Caffeine + Warfarin + Dextromethorphan + Midazolam
Experimental: Abemaciclib + Drug Cocktail Abemaciclib administered orally every 12 hours on Days 1 - 12 of Period 2 with a single dose of drug cocktail administered orally on Day 8 of Period 2.	Drug: Drug Cocktail Administered orally Other Names: Caffeine + Warfarin + Dextromethorphan + Midazolam Drug: Abemaciclib Administered orally Other Names: LY2835219
Experimental: Abemaciclib - Period 3 Abemaciclib administered orally every 12 hours on Days 13 to 28 of Period 3. Participants may continue to receive abemaciclib until discontinuation criteria are met.	Drug: Abemaciclib Administered orally Other Names: LY2835219
Experimental: Abemaciclib - Period 4 Abemaciclib administered orally every 12 hours on Days 1 to 28 of Period 4. Participants may continue to receive abemaciclib until discontinuation criteria are met.	Drug: Abemaciclib Administered orally Other Names: LY2835219

Outcome Measures

Primary Outcome Measures

Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine, S-Warfarin, Dextromethorphan, and Midazolam [Baseline through Period 2 Day 12]
Pharmacokinetics: Area Under the Concentration versus Time Curve (AUC) of Caffeine, S-Warfarin, Dextromethorphan, and Midazolam [Baseline through Period 2 Day 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarah Cannon Research Institute at HealthOne	Denver	Colorado	United States	80218
2	IU Simon Cancer Center	Indianapolis	Indiana	United States	46202
3	University of Kansas Hospital	Fairway	Kansas	United States	66160
4	Mary Crowley Cancer Research Center	Dallas	Texas	United States	75230
5	South Texas Accelerated Research Therapeutics, LCC	San Antonio	Texas	United States	78229-3307

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company