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

I3Y-MC-JPCB -

The purpose of this study is to evaluate how abemaciclib interacts with a drug mixture containing caffeine, warfarin, dextromethorphan, and midazolam and how this interaction affects blood levels in the body.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Advanced Cancer
What the trial is testing?
Abemaciclib and Drug Cocktail (Caffeine, Dextromethorphan, Midazolam, Warfarin)
Could I receive a Placebo?
No
Enrollment Goal
48
Trial Dates
Mar 8, 2016 - Jan 6, 2021
How long will I be in the trial?
Your participation could last up to 4 months or longer if you continue to take the study drug.
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have a diagnosis of cancer that is advanced and/or metastatic and is confirmed by histology or cytology

  • Participants must discontinue 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

Participants Must Not:

  • Participants must not have history or presence of significant bleeding disorders

  • Participants must not have known active uncontrolled or symptomatic CNS metastases

  • Participants must not have a primary liver tumor

  • Participants must not have lymphoma or leukemia

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