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Completed

NCT Number: NCT02688088

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

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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Key information

Conditions

Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sarah Cannon Research Institute at HealthOne, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Cocktail

Drug

Administered orally

Other names: Caffeine + Warfarin + Dextromethorphan + Midazolam

Abemaciclib

Drug

Administered orally

Other names: LY2835219

Primary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine

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

    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.

  2. Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin

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

    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.

  3. Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan

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

    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.

  4. Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam

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

    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.

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

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

    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.

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

    Time frame: Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hr Postdose

    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.

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

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

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

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

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

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

Secondary outcomes

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

    Time frame: Day 8: Baseline, 24 h postdose

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

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

    Time frame: Day 8: Baseline, 24 h postdose

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

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

    Time frame: Day 1: Baseline, 24 h postdose

    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.

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

    Time frame: Day 1: Baseline, 24 h postdose

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

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

    Time frame: Day 8: Baseline, 24 h postdose

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

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

    Time frame: Day 8: Baseline, 24 h postdose

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Feb 23, 2016
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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