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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688088
Recruitment Status : Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
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 : March 8, 2016
Actual Primary Completion Date : February 4, 2018
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Caffeine + Warfarin + Dextromethorphan + Midazolam

Drug: Abemaciclib
Administered orally
Other Name: 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 Name: 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 Name: LY2835219




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688088


Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, United States, 80218
United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Hospital
Fairway, Kansas, United States, 66160
United States, Texas
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
South Texas Accelerated Research Therapeutics, LCC
San Antonio, Texas, United States, 78229-3307
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02688088     History of Changes
Other Study ID Numbers: 15537
I3Y-MC-JPCB ( Other Identifier: Eli Lilly and Company )
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 15, 2019
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Midazolam
Dextromethorphan
Caffeine
Warfarin
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Antitussive Agents